Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Siemens has become aware of potential errors that may occur while performing a biopsy. the system may freeze and biopsy functionality may become unavailable in the following situations:- drop of the compression force, e.G. this may occur due to a patient's sudden movement during the active targeting phase- use of the inversion tool while the scout image is active during the targeting phase.As a result of system freeze, the biopsy may have to be repeated.
Acción
Siemens will release a software update to resolve the issue. Siemens service engineer will contact affected customers to schedule the software update. In the interim, Siemens is advising users to follow these instructions:
1) Do not close the error message window when it is displayed. Instead, cancel the active target before closing the window. Users can start all over after the completion of these steps.
2) Users are advised not to use the inversion tool while the scout image is active.
In the event of a system freeze, the acquisition workplace must be rebooted.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
It has been identified that the expiration date is incorrect on the outer packing label for several lots of the roth net device. the printed expiration date is earlier than the actual expiration date. please note that all individual roth net devices inner labels reference the correct expiration date. there is no impact on the performance of the product.
Acción
Device Technologies is advising users to quarantine affected products prior to returning them for replacement stock. This action has been closed-out on 05/07/2017.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
There is potential for radio frequency (rf) interference to alter wireless communication from the model 3200 programmer, which in rare instances may cause an s-icd to perform an unintended command, such as the unintended initiation of pg-based tachyarrhythmia induction of a patient, or a command that results in therapy being unavailable after the telemetry session has ended, both of which could result in patient death. this behaviour can only occur during an active, in-clinic interrogation/programming session with the model 3200 s-icd programmer. there is no risk of this behaviour occurring when the latitude patient management system communicates with an s-icd in an ambulatory setting. to date, a total of ten observations of unintended programming commands or data changes have been observed, with no instances of permanent injury or death.
Acción
Boston Scientific is developing software to mitigate this issue. Until updated software is available, recommendations that mitigate the risks associated with this issue, and which are detailed in the customer letter, are to be followed.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The manufacturer, trinity biotech, has identified a potential for misdiagnosis with lot f117009. an investigation identified that this lot displays a level of accuracy variation outside the historical qc product release process control charts for normal range controls, despite falling within the qc acceptance specification. investigation testing has shown that there is objective evidence that the accuracy issue affects the normal patient range and not the deficient range with a potential health hazard of a false positive result (normal patient diagnosed as deficient) or an invalid test result occurring.
Acción
Immuno is advising customers to immediately discontinue use of the affected lot and destroy any remaining product. Laboratories are to consider the need to review results previously generated with the affected lot. Immuno will organise replacement kits.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Internal tests conducted by cepheid show that certain lots of xpert bcr-abl monitor (bcr-100n-10) meet performance claims up to 12 months after the date of manufacture instead of the current expiration dating (up to 24 months). assay stability data beyond 13 months under reported the amount of bcr-abl mrna transcript at the lowest level. the claimed performance for the assay allows for a 2-fold variance in the ratio of bcr-abl to abl mrna transcripts whereas at 25 months a 3-fold difference was observed. at 13 months a 1.8-fold variance was observed, which is within the claimed product performance variability. although outside of the stability limits, the detected level of bcr-abl mrna transcript is correctly called as bcr-abl detected.The expiry dates of affected lots have changed to reflect the new 12 month timeframe. as a result, lot 1000026629 expired as of 4 jan 2017, and lot 1000027258 and 1000040993 will expire in march 2017 and august 2017, respectively.
Acción
Cepheid is advising, based on the assignment of the new expiry date, that Xpert BCR-ABL Lot 1000026629 (Cartridge Lot 21503) expired on 4 Jan 2017. Customers are to stop using and dispose of product from this lot. Cepheid will provide replacement product. Results obtained using this lot from tests run after 4 Jan 2017 should be reviewed for outliers not associated with known clinical factors (eg. therapy compliance).
For Lot 1000027258 (Cartridge Lot: 21703) and Lot 1000040993 (Cartridge Lot: 22402), the new expiry dates are 1 Mar 2017 and 15 Aug 2017, respectively. Customers are to stop using and dispose of remaining product from these lots after the newly assigned expiry dates. Cepheid will provide replacements for product remaining after the new expiry dates.
This action has been closed-out on 28/02/2018.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Carestream health australia pty ltd has received a report of unintended motion of a drx revolution mobile x-ray system caused by a loose pivot screw in the drive handle. there was no resulting injury. no other reports of this type have been received since the device was introduced into commercial distribution in 2009, however this problem could manifest itself in additional units over the lifetime of the device. if this failure was to recur in the field, the likelihood of injury would be mitigated by both bump stop and estop systems on the device – which the driver/operator could use. however, given the weight of the device and the speed at which it can travel, should the device make contact with a person, the subsequent collision or crushing injury could be serious e.G. fractured/broken bones.
Acción
Carestream is advising users that they will be inspecting affected serial numbers and replacing the lower handle assembly and internal side covers of the device. In the interim, the device can continue to be used; however it is recommended that routine user inspections of the drive are continued and should any part show a visual problem or fail to operate as expected, the device should be removed from use and a service call placed to Carestream.
This action has been closed-out on 01/03/2018.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
For two lots of the irt screening assay kit (e-kr-480) there is a computer transcription error in the qc sheets for the value of standard 3, where the value is 50 µg/l instead of 60 µg/l. it has been determined via internal testing that if the cut-off value in use by the laboratory is 90 µg/l or higher, there is no risk of false positive results. for a cut-off value lower than 90 µg/l, the clinical impact depends on the cut-off value fixed by the laboratory/physician. so, depending on the cut-off value used, there may be a risk of a false positive result. as the irt screening assay is a screening test, all positive must be retested using a confirmatory method. thus, false positive patients will be retested with other tests (dna etc.) and found negative without harming the health of the patient being a false positive.
Acción
Abacus ALS is advising users that the correct value of Standard 3 is 50ug/mL (rather than 60ug/mL). The customer letter should be discussed with the Medical Director, with consideration given to the need for a look-back of results previously generated using the affected lots.
This action has been closed-out on 01/03/2018.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
A remote possibility exists of incorrect allocation of customer demographic information against a sample in a specific situation. in a situation where the patient demographic information for a sample is not entered at the host computer and if the sample position is manually changed after being read by the barcode terminal, the customer demographics may be incorrectly allocated to the wrong patient results. one complaint worldwide has been received for this issue and in this instance, the user was not following the instructions for use, which clearly indicate that tubes should neither be removed nor inserted from the tube rack after a sample processing run has started. however, a software issue has also been identified with this system.
Acción
Sysmex is preparing a software patch for mandatory upgrade, which Roche Diagnostics’ personnel will install on the affected systems (software expected by end January 2017). Roche Diagnostics Australia will contact customers to arrange the install. In the interim, users are to ensure that:
- They do not remove a rack in transit, or insert a rack or sample in anything other than the feeder when analysis is in progress;
- If a STAT sample needs to be processed, they perform a manual analysis or off-line analysis;
- If any sample results are sent to “Pending”, they perform a delta check;
- Patient information is entered at the host computer and use both sample and patient ID.
This action has been closed-out on 01/03/2018.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The manufacturer (isomed) has advised that for procedures requiring embolectomy/thrombectomy of arteriovenous (av) fistulas, the catheter used should have the tensile strength to withstand at least 9n of resistance. after extensive testing, it was determined that the maximum resistances of the isomed 2f, 3f & 4f single lumen arterial embolectomy catheters are: 3n, 5n & 9n respectively. to minimise the risk of vessel damage, balloon rupture or tip detachment in av fistula procedures, it is recommended that single lumen arterial embolectomy catheters of less than 4f (i.E. 2f & 3f) should not be used for these procedures. the “warnings” section of the ifu has been updated to include this information.
Acción
Medical Specialties Australia is advising users to immediately inspect their stock for affected products. IFUs in the affected stock are to be discarded and replaced with a copy of the updated IFU. This action has been closed-out on 26/05/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Siemens healthcare diagnostics has confirmed a negative bias for the advia centaur ft4 assay when used with calibrator a kit lots ending in 90 on the advia centaur, advia centaur xp and advia centaur xpt systems. upon internal investigations siemens observed an average bias, when compared to calibrator a lots ending in 89, of -11% (range -28 to 7%) for ft4 dose of < 0.89ng/dl (<11.5pmol/l), -5% (range -14 to 0%) for 0.89ng/dl to 1.76ng/dl (11.5 to 22.7pmol/l) and -7% (range -16 to 3%) for >1.76ng/dl (>22.7pmol/l). when this issue occurs, the potential exists for misinterpretation of ft4 values as below the reference interval listed in the ifu when truly normal. in addition, siemens healthcare diagnostics confirmed the potential for calibration failures due to above limit calibrator rlu %cvs when using calibrator a kit lots ending in 90 with the ft4 assay. the performance of the ft4 assay when used with calibrator a kit lots ending in 90 on the advia centaur cp system is not affected.
Acción
Siemens is advising Advia Centuar FT4 assay customers using the Advia Centaur, Centaur XP, Centaur XPT Systems to discontinue use of and discard the affected Calibrator A kit lots ending in 90, and to use Calibrator A kit lots ending in 91 to calibrate the FT4 assay on these Systems. Siemens will replace affected stock. The information provided in the customer letter is to be reviewed by the Medical Director, with a review of previously generated results at the discretion of the laboratory. Advia Centaur FT4 assay customers using the Advia Centaur CP System can continue to use all available Calibrator A lots including those ending in 90.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Maquet has identified an issue with the li-ion battery used with the cardiosave iabp. if the li-ion battery is accidentally dropped, the impact may cause the battery to vent. in addition to the risks contained in the warnings section of the operator/user instructions, battery venting has the potential to create smoke, a foul odour, and sparks. there has been no reported patient harm or adverse events attributable to this issue. there have been 3 reported occurrences of the battery venting when dropped to date.
Acción
A Maquet Representative will schedule an on-site visit to affix a “Do Not Drop” label on the battery and provide additional instructions which will indicate to take extra care to avoid dropping the battery.
Additionally, Maquet is in the process of providing a re-usable transport and storage case which will allow for the transport and storage of spare batteries. Future shipments of CARDIOSAVE Li-Ion batteries from Maquet will be shipped in the re-usable transport and storage container. Users are advised not to take spare batteries for transport applications, until they are provided with the re-usable transport and storage case.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Physio-control has become aware of a potential device issue where the lifepak 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (relay) installed on the therapy printed circuit board assembly (pcba). a malfunction of the relay can be identified during the user test of the device. if the user test fails, the device will illuminate the service indicator icon on the device. if the user test passes, the device is safe to use.
Acción
Physio-Control is contacting customers with LIFEPAK 15 devices that contain the potentially affected Relay component to arrange for a device correction. This correction will include the replacement of the Therapy PCBA. If needed, loaner devices will be made available while the repairs are being made. In the interim, users are advised to continue to perform the User Test as outlined in the Daily Operator’s Checklist within the LIFEPAK 15 Operating Instructions. If the device fails the User Test, contact Physio-Control immediately to arrange for correction of the device. This action has been closed-out on 25/05/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Recent customer feedback has alerted bmdi tuta healthcare to an issue with the sleeve index system (sis) on the handwheel coupling. this component is the interface between the regulator and the wall fitting. the groove in the handwheel has been manufactured with an incorrect dimension. due to this incorrect dimension it is possible to incorrectly connect the suction regulator to the air outlet for surgical tools.
Acción
Users are advised to examine all affected suction regulators installed in their facility and ensure that they are connected to the correct source. This can be identified by the yellow suction label on both the regulator and the wall outlet. BMDi TUTA will arrange for the sleeves to be shipped to affected facilities for rework. Rework the handwheel component in accordance with the rework instructions provided in the customer letter.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Siemens healthcare diagnostics has confirmed that under very rare circumstances a false negative result may be reportable. the issue may only occur under the following conditions:- the initial result is falsely flagged with an antigen excess error that triggers an automatic reanalysis in a 1/19 dilution; and- the raw signal that is generated from the reanalysis is below the limit of blank (lob) of the method.Under such conditions the low reanalysis raw value may be strongly affected by the signal noise of the optical system and can generate an erroneous low optical raw value. this raw value is corrected by the dilution factor and can then be incorrectly calculated from the calibration curve as a falsely low result.
Acción
Siemens is advising customers that the threshold for “Min Range” of the extrapolation needs to be changed within the Innovance D-Dimer assay setting on the Sysmex system as follows:
- In the CS software, Select “Menu”
- Select “Settings”
- Select “Assay Group Settings”
- Select “Innovance D-dimer” assay
- Double click assay parameter “INN DDi”
- Under the “Calculation Method” tab, change the current “Extrapolation” threshold for the “Min” extrapolation range from 0.01 to the new threshold of 1.00
- Select “Save” and restart CS-System software
After the restart, the system will work with the new setting.
Siemens is also recommending that laboratories discuss the customer letter with their Medical Director and consider the need for a look-back of previously generated results that may be affected by this issue.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Physio-control has received reports where lifepak 1000 defibrillator units have shut down unexpectedly during patient treatment. customers have attempted to use their lifepak 1000 defibrillator and the device has shut down unexpectedly due to an intermittent connection between the battery and the device electrical contacts. a defibrillator in this scenario may not be able to deliver therapy during a resuscitation attempt, which may expose patients to the risk of serious harm or death. physio-control has determined that this intermittent connection is a result of wear and subsequent oxidation formation between the battery and device electrical contacts. this condition can occur over time in lifepak 1000 devices that are exposed to vibration, and have a battery installed for long periods of time. this issue can potentially affect any lifepak 1000 device.
Acción
Physio-Control is contacting users and advising them to immediately remove and reinstall the battery from their device(s). Users are also being advised to implement a weekly schedule of battery removal and reinstallation for all LIFEPAK 1000 devices. The removal and reinstallation of the battery will clean the contacts of oxidation and will reduce the likelihood of this issue from occurring. Physio-Control will be initiating a hardware device correction for all affected LIFEPAK 1000 devices and will contact customers to schedule device corrections once the hardware correction is ready for implementation.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Pentax medical is informing customers about a potential issue associated with the distal cap of the ed-3490tk and offer recommendations intended to reduce the potential risk for contamination and subsequent patient infection. pentax is also reminding customers to follow the validated manual reprocessing instructions that pentax issued to all pentax model ed-3490tk duodenoscope customers in april 2016. this action was undertaken prior to consultation with the therapeutic goods administration (tga).
Acción
Pentax is advising users that the validated manual reprocessing procedures included in the current Instructions for Use (RIFU 6217001 S059 R01, April 2016) remain the same. PENTAX reminds its customers of the importance of using the ED-3490TK according to its current labelling. Customers must ensure that all reprocessing personnel are knowledgeable and thoroughly trained on the current Instructions for Use for manual reprocessing of these devices. Meticulous cleaning of the elevator recesses and attention to following all reprocessing instructions are required.
Additionally, PENTAX recommends that users immediately remove from use any ED-3490TK duodenoscope that shows visible signs of wear or physical damage.
PENTAX will provide annual inspection and servicing to all customers with ED-3490TK duodenoscopes. During on-site inspections, PENTAX fie
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
On the abl90 series analysers, the sample type “cord blood” has been changed into the two sample types “cord blood arterial” and “cord blood venous". this change took place with software version 3.1 mrs. despite the selected sample type being correctly displayed on the abl90 series analyser itself, the analyser will transmit the less specific sample type "cord blood" to a his/lis or middleware system. the described error may in a worst-case scenario lead to minor foetal hypoxic stress not being immediately recognised if the clinician was to use data from the his/lis or middleware system to determine treatment. this may cause a minor delay of necessary treatment of the newborn infant.
Acción
Radiometer is advising operators and clinicians using the "cord blood" sample results from a HIS/LIS or a middleware system to determine treatment to be aware that "arterial" or “venous" is not transmitted from the Analysers. Users are further advised that they will be notified when the new software fix is available for installation.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
There is an update of the operation manual for the oer-aw endoscope reprocessor to instruct users of non-detachable distal cover type duodenoscopes, such as the tjf-q180v duodenoscope, to follow the pre-cleaning and manual cleaning as stated in the duodenoscope’s reprocessing manual prior to setting them into the oer-aw.The following warning has been added to the list of compatible endoscopes/connecting tubes and chapter 4 “basic endoscope reprocessing operations” of the oer-aw operation manual - "when reprocessing the following non-detachable distal cover type duodenoscopes using oer-aw, conduct pre-cleaning and manual cleaning as detailed in each duodenoscope’s reprocessing manual".
Acción
Olympus is requesting users to inspect their inventory and replace any existing OER-AW Operation Manuals and List of Compatible Endoscopes/Connecting Tubes with the latest version supplied.They are further advised to implement the instructions enclosed in the updated OER-AW Operation Manual. This action has been closed-out on 06/07/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Due to a memory issue, users are shown a warning message about unexpected error and possible incorrect data integrity. a reboot of the workstation computer after having received the warning message prevents the issue from occurring. at this stage, there has been one instance whereby the warning instructions were not followed and resulted in the image of one patient being archived in another patient’s record.
Acción
In order to prevent this issue, Agfa HealthCare is advising users to conduct a daily reboot of their workstation by completely turning off the computer and then restarting it. Users are further advised to follow all warning instructions as indicated on their NX workstation and reboot the workstation’s computer if a warning message appears. A new version of the NX software (3.0.9000) will be released shortly and users will receive this upgrade to their installations accordingly.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Due to a known error in nvidia graphics processing unit (gpu) card drivers, raysearch has prevented gpu based computations for very large computation problems. in an incorrect citrix xenapp configuration, the gpu may not be correctly identified and the erroneous calculation may be allowed. if this occurs, accelerated computation on gpu may give incorrect results for very large computation problems. dose computation will be affected if the dose grid contains more than 134217728 voxels for a photon plan or more than 67108864 voxels for a carbon ion plan. the main effect on calculated dose is that it may be incorrectly set to zero in parts of the dose grid. normally this would be highly detectable. there may also be some smaller impact on the dose in the non-zero region. deformable registration may be affected for large image sets. in a correct citrix xenapp and gpu installation by raysearch, the issue would not occur.
Acción
Users are advised to verify the GPU settings on each of the Citrix XenApp servers according to the instructions in the customer letter. A correct configuration of the RayStation GPU settings will show a graphics board that has been verified by RaySearch. Add the RSL-D-61-320-EN-1.0 RayStation 4.5, 4.7, 5 and 6 Additional System Environment Acceptance Test Protocol GPU to the location of the RayStation manuals. The tests in the Additional System Environment Acceptance Test Protocol GPU must be performed in addition to the tests in the System Environment Acceptance Test Protocol to verify GPU computations whenever the hardware or software platform is changed.
This action has been closed-out on 01/03/2018.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
A biomérieux investigation has confirmed a potential performance issue on strain categorisation for streptococcus pneumoniae and for enterobacteriaceae strains limited to oral cefuroxim breakpoints based on 2016 clsi clinical standards. the potential hazard is to obtain minor error (susceptible instead of intermediate or intermediate instead of resistant) on strain categorisation for streptococcus pneumoniae and for enterobacteriaceae strains only when using the 2016 clsi clinical breakpoints defined for cefuroxime oral forms. products perform within specification when using the 2016 eucast guidelines.
Acción
bioMérieux is advising customers who use the 2016 CLSI clinical guidelines that they may continue to use the ETEST XM256 (Cefuroxime) Foam and SPB products and can directly report results for Streptococcus pneumoniae and Enterobacteriaeceae when oral breakpoints are used if they apply the reporting recommendations provided in the customer letter. bioMérieux is also advising that for tests previously performed, users are to identify any possible false Susceptible results, analyse the related risks and determine appropriate actions if relevant.