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
Two laptops returned from medtronic japan distribution centre alleged a power supply issue. the defective power supply could impact the performance of the gui by introducing latency (delay) in its performance. however, once the units are turned on while connected to their respective power supplies (dell 90 watt ac adapters), the users would be warned by the "ac alert message" that is shown on the screen during the boot up process. this issue is unlikely to present a hazard to either the patient or the user. there have been no complaints or adverse events reported for this issue from the field.
Acción
Medtronic will replace the affected power supply units with unaffected stock. This action has been closed-out on 27/01/2017.
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
Quick connects provide directed flow of sterilant use dilution and rinse water into the internal lumens of specifically identified endoscopes to achieve liquid chemical sterilisation.Steris has learned that one of the hysteroscope models (karl storz 11264bbu1) listed for processing in stqkc1736int and st-qkc-1737int has one inlet port rather than two inlet ports as indicated in the quick connect processing instructions. a user who connects the karl storz 11264bbu1 hysteroscope according to the processing instructions will observe an unused quick connect port adapter. steris performed testing on the karl storz 11264bbu1 hysteroscope which confirmed that despite this unused port adapter, the flow provided to the lumen is more than adequate. therefore, the efficacy of the liquid chemical sterilisation process is not affected. however, there is potential for user confusion due to the unused quick connect port adaptor if used for this hysteroscope.
Acción
Device Technologies is advising users that updated labelling kits and instructions for use will be provided. The impacted hysteroscope can be processed using the ST-QKC-1705INT processing manual. This action has been closed-out on 30/01/2017.
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
Hill-rom has received reports that the backrest actuator on the avantguard 1600 beds may experience a jolted motion, noise (clanking or chattering), premature wear, or backrest functionality loss when a load is applied to the backrest section. these issues do not affect the cpr functionality in case of emergency.The reported issue is unlikely to cause adverse health consequences.
Acción
Hill-Rom has developed a correction and will contact the affected facilities to modify the affected beds. The CPR function is still operational in case of emergency. For this reason, the device can continue to be used whilst awaiting the correction. If however, the unit experiences a loss of backrest functionality, users are advised to take it out of service and contact Hill-Rom.
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
Alcon has received reports concerning the inclusion of unplanned arcuate incisions on printed, saved (.Pdf) or exported surgical plans. this situation only occurs when the verion reference unit (vision planner) is used to create a surgical plan for non-alcon toric intraocular lenses (iols) that is used with the alcon verion digital marker lensx laser system. surgical plans for alcon toric iols as well as all spherical iol regardless of brand are not affected. these unintentional surgical plan arcuates can occur if the deactivated ‘iol 100% – ri 0%’ slider bar is unintentionally activated by the user in the planning software. this directs the software to include the addition of arcuates for the surgical procedure and can only be seen on the exported, saved (.Pdf) or printed surgical plans. if the additional arcuates are performed this may lead to an astigmatism overcorrection resulting in reduced unaided visual acuity.
Acción
Alcon is providing users with work around instructions to follow as an interim measure. A software update will be installed on all affected systems as a permanent fix.
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 affected part number and lot numbers are out of specification at the thread. this is related to a non-conformance where the thread height of these screws is under-sized. it was also identified that the cross section of the affected area is less than that of conforming screws such that the thread height of the screws is under-sized.The decreased thread height may alter the self-drilling feature and result in difficulty inserting the screw. if the surgeon finds that the screw is not inserting as anticipated, the surgeon may choose to use a different screw or drill a pilot hole to insert the screw. attempting to insert additional screws or possibly drill with another instrument could result in a surgical delay. should the user be able to insert the screw the decreased thread height may significantly reduce the retention ability of the screw in the bone. these issues may require medical or surgical intervention to secure components or stabilise the structure or bone.
Acción
Johnson & Johnson Medical (JJM) are advising users to remove and return all opened Titanium Low Profile Neuro Screw; Self- Drilling 3mm screws in stock, and to remove and return only affected lots of unopened screws in their original packaging. This action has been closed-out on 25/01/2017.
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
It has been identified that the specified affected lots of the drill sleeve may not couple with the protection sleeve (part number 356.705) due to the potential for interference between these two devices. in the event that the drill sleeve would not couple with the protection sleeve, a surgical delay would likely occur as the situation is assessed and the next steps are determined. if a drill sleeve is not used, the accuracy of insertion of the guide wire and/or proximal locking screw could potentially be reduced and may potentially result in damage to surrounding structures or a mal-union/non-union requiring a re-operation.The guide sleeve also provides mechanical support of the wire. thus, if the sleeve is not used, the potential exists for guide wire breakage and an adverse tissue reaction if the entire guide wire is not removed despite the guide wire being implant grade.
Acción
Johnson & Johnson Medical (JJM) is advising users to quarantine all affected stock and return.
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 received reports that, in some cardiosave iabps, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates. when the scroll compressor fails, one of two high priority alarms will appear on the iabp display and patient therapy could be interrupted. the high priority alarms are “autofill failure” and “iab catheter restriction”. if either of the high priority alarms cannot be resolved, the event may be attributable to the scroll compressor failure and therapy to the patient cannot be manually restarted.In this situation and where supported by the iabp to stabilise their haemodynamic status, patients present with critical conditions (particularly those in transit), there is a risk for severe and possible irreversible injury.There are no complaints reported associated with a patient injury or death.
Acción
Maquet is providing work around instructions for users to follow as an interim measure. A software upgrade will be installed as a permanent correction. An updated operator’s manual is being provided which includes additional important information regarding the configuration, alarms in the presence of ESI and self-checks for the compressor. Users are advised the units can continue to be used while the software is being implemented, however it is recommended that if available, they use an alternative unaffected device based on the individual benefit-risk assessment and particularly for patients in transit. If users choose to use an affected CARDIOSAVE IABP it is recommended that an alternative device is available for back-up.
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
An issue can occur after the export of segmentation results of the left atrium created on syngo x workplace to an electro-anatomical 3d mapping carto system. after importing, the segmentation result appears mirrored at the carto system, and can't be used for the ablation procedure. although unlikely, there is a risk of serious health effects if the incorrect image is used for ablation.
Acción
Siemens is advising users that a software upgrade will be performed as a permanent correction. Users are advised to stop using any segmentation result for export to the CARTO system until the software upgrade is performed. This action has been closed-out on 25/01/2017.
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
Issues have been identified that may arise on the cios alpha unit:a) if the system language is set to english and the yyyymmdd date format is used, the patient’s date of birth received through the dicom worklist and query/retrieve will be displayed with month and day reversed for patients who have birthdays on days 1 through 12. birth dates for days 13 through 31 are displayed correctly. the issue only appears to happen for days 1 through 12.B) system crash may occur during dvd live recording if radiation is released while the dvd icon on the flc status bar is blinking. in this case error messages will be displayed and a system reset is necessary.C) sporadically the system will not be ready for radiation during reconnection of the trolley to the main unit. a system reboot is necessary.The issues may result in a delay in diagnosis or therapy while the system is rebooted.
Acción
A modification of Cios Alpha is being developed by Siemens that will resolve the issues. The roll out is planned for end of 2016. In the interim, Siemens is providing users with work around instructions as follows:
a) The user can prevent the issue by changing the date format to DDMMYYYY. This format will work properly for all dates. If this may not be practicable, the user should be aware that the day and month may get reversed.
b) The user is advised not to release radiation as long as the DVD icon is blinking.
c) Please do not disconnect and re-connect the trolley if the system is needed immediately.
This action has been closed out on 14 June 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
Philips healthcare has identified through customer complaints and internal testing that uncontrolled geometry movements can occur when the system is not switched on/off regularly. due to the nature of the problem, the user will perceive a gradually increased sluggishness. upon activation of the iu controls an uncontrolled geometry movement can occur. the uncontrolled movements are immediately stopped upon release of the iu controls. all safety measures such as current sensing, 3d model and bodyguard remain intact avoiding serious harm to patient and bystander. a system reboot will restore normal system operation.
Acción
Philips is advising users to regularly restart the system as per the Instructions for Use (IFU) once a day to avoid uncontrolled movements. A software update will be provided as a permanent fix. 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
Topaz microdebrider wands has failed to meet shelf-life at the expiration date indicated on the product labels during internal functional testing. it has been found that saline may leak from the proximal end of the handle during use, and the spacer between the active and return electrodes may be displaced. this can potentially lead to the spacer being unintentionally retained in a patient, which may lead to a prolonged procedure time.
Acción
Smith & Nephew is advising users to discontinue use and return the affected product. Smith & Nephew will be able to provide users with alternate products. This action has been closed-out on 25/01/2017.
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
Claveguard has been advised that diathermy pencils manufactured under batch number 181214sy have an issue with the quality of the ink used for the sterility check mark, which may compromise the ability to clearly discern the colour change. as a precautionary measure, claveguard is recalling the affected batch.
Acción
The sponsor ClaveGuard advises customers to discontinue use of any remaining stock of the affected batch prior to their quarantine. The sponsor will arrange for the replacement and recovery of the affected units. This action has been closed-out on 16/02/2017.
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 has identified that refurbished e.Cam systems have been delivered to users without the full user documentation. the training provided to users provides the necessary cautions and warnings; however these manuals provide additional instructions and reference materials necessary for the safe and proper operation of the systems.
Acción
Siemens is providing users with the full instruction manual.
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
Zimmer spine has received complaints of closure top loosening. loosening may occur when there is off-axis driver pressure and when the rod is not fully seated prior to application and final tightening of closure top.The most probable risks associated with off-axis tightening of the closure top and final tightening of the closure tops prior to the rod being fully seated in the screw is loosening of the closure tops which may result in a revision surgery.
Acción
Zimmer Spine is providing users with additional technique guidance in advance of an updated Surgical Technical Manual for the Virage OCT Spinal Fixation System. Surgeons are advised to adhere to the additional guidance provided with the customer letter to minimise the risk of improper locking of the construct.
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
Smith & nephew pty ltd. has identified a risk that some external power units have the potential to overheat and induce an electric shock whilst in use with the renasys go npwt pump. only certain external power units are affected by this issue. to date there have been 2 reported adverse events related to this issue, including one electric shock – discomfort, and one minor burn.
Acción
Smith & Nephew is advising users to disconnect all affected power units from the mains electrical supply and switch to an unaffected power unit. The pump will continue to provide treatment as the device will run off its internal battery during this time. Affected units can be returned to Smith & Nephew and will be replaced with unaffected stock.
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
Ortho clinical diagnostics is issuing this notice due to an unlikely scenario in which a user inappropriately removes or interchanges samples in an onboard sample rack or removes an onboard dilution tray after making a reagents load/unload request. if an unexpected change is made in a load station location that was not selected via the graphical user interface (gui), the system will not detect the change. if users deviate from normal process for changing patient samples, these can be associated with another sample id, potentially leading to erroneous test results. in the unlikely event the error occurred, it may lead to an incorrect rh(d) or incorrect cross matching result. there have been no reports of patient injury.Update: ortho has advised an additional unlikely scenario where it is also possible for a user to unexpectedly remove or interchange diluents in a location that was not selected on the graphical user interface (gui) after making a reagents load/unload request.
Acción
Ortho Clinical Diagnostics is advising users to ensure samples, diluents and dilution trays are loaded and unloaded using the Graphical User Interface (GUI). The issue will be addressed in a future software version. Any concerns regarding previously generated results should be discussed with the Laboratory Director. This action has been closed-out on 02/02/2017.
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
Stryker neurovascular has become aware that the product labels (pouch and carton) for the neuroform atlas stent catheter contains an incorrect conversion from inches to millimetres for the minimum catheter diameter dimension (0.0165in 0.69 mm). the correct dimensions are 0.0165in (0.42mm). this labelling discrepancy could lead to a physician selecting a catheter which is too large. the hazard associated with this is that the stent would prematurely deploy during transfer into the catheter. if this happens, additional procedure/treatment would be required and the patient may be exposed to increased time under anaesthesia.
Acción
The sponsor is advising that the affected devices can continue to be used, provided that the correct dimensions listed in the product directions for use (DFU) are followed. This action has been closed-out on 23/01/2017.
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
The manufacturer has identified a potential defect in the fixed laser eye safety filter assembly for the above laser systems. under certain conditions there is potential for the glass of the safety filter optics to crack on their lower edge due to pressure applied on them by their retaining plate which in turn could damage the laser safety coating on the optics.The safety filter is located on the binocular mount of the delivery head, and is in the user’s optical viewing path and as such provides protection to the user’s eyes from any diffused reflected laser light during the laser treatment.There is a risk associated that if the above failure mode occurs, there is a remote possibility that during laser treatment the user could be exposed to any diffused reflected laser light.
Acción
Ellex Medical is advising users to check the affected devices to see if there is any green laser light visible while firing the laser. If so, remove the device from use and notify Ellex. Ellex will be replacing the filters on all affected systems with a newly designed filter. This action has been closed-out on 27/01/2017.
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
Intuitive surgical has found that compact flash cards used in touchpads on specific da vinci si and xi surgical systems to save user preferences, have the potential to become corrupted when the touchpads experience an abrupt power loss and/or are powered on and off within a short period of time. the corruption of the compact flash occurs when power is cycled. if the compact flash has been corrupted, the da vinci system will display a fault during the start-up of the system. in the worst case scenario, the da vinci surgical system will encounter a non-recoverable fault, preventing use of the system. the error typically presents itself during start-up, so will not likely occur during a procedure (unless a mid-procedure power restart is required).
Acción
Device Technologies is advising users that a representative will be replacing the affected compact flash cards with unaffected products. This may require users to re-enter their user preferences. This action has been closed-out on 27/01/2017.
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
The european medicines agency (ema) has clarified their recommendation for 20 psi (as opposed to 20-25 psi) pressure to be used when spraying evicel with the 45cm tip during laparoscopic surgery. as a result, the labelling of omrix pressure regulators in australia need to be updated and the sticker label on each pressure regulator will be replaced to reflect this change.Also, in an effort to enhance consistency between the labelling of the omrix pressure regulator and the omrix evicel solutions for sealant, the ifu for the pressure regulator has been updated to remove the following statement;"spray application of evicel should not be used in endoscopic procedures where the minimum recommended distance of 4 cm cannot be maintained. for laparoscopic procedures using accessory tips, see the recommendations in table 2".
Acción
Johnson & Johnson Medical (JJM) is providing users with the updated IFU and replacing stickers on the Omrix Pressure Regulators to reflect the new recommendation of 20psi when spraying Evicel with a 45cm tip during laparoscopic surgery. This action has been closed-out on 30/01/2017.
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
An internal technical investigation by oxoid limited, part of thermo fisher scientific, has identified that individual bottles of oxoid nitrocefin (+ reconstitution fluid), may produce weak beta-lactamase reactions. not all of the lot is affected; however, continued use may result in delayed or false negative reporting.
Acción
Thermo Fisher is advising users to inspect stock and remove the affected lot from use. A review of previously generated results is at the discretion of the Laboratory Director. This action has been closed-out on 02/02/2017.
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
An issue has been identified regarding an unintended behaviour of the system's result-generation software. it has been observed that an internal control displayed a no baseline error but the assay result for that well was not reported as an invalid result. the correct software behaviour is to report the assay result as invalid result when the internal control for that well displays a no baseline error. this issue allows for the possibility that an incorrect assay result could be reported for a sample when the result should be invalid and the sample repeated. there is an extremely low risk of false negative results.
Acción
Siemens is advising users to review each report for the affected Versant IVD assays to identify if there are any No Baseline errors in the IC channel of any wells. If a No Baseline error occurs for the Internal Control of any well, users must not report the assay result for that well and repeat the test. A review of previously generated results is at the discretion of the Laboratory Director.
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 have received complaints regarding incidents where collimator change activities have resulted in operator injury. the investigation found that these incidents may have been avoided by operators properly following specified instructions. the system was designed to safely store and exchange collimators, however if the instructions are not followed serious injuries, such as broken bones and lacerations, may occur. siemens have determined that although the existing user manual is correct, additional supplemental instructions, with the inclusion of visual aids, may further clarify and emphasise the proper collimator change process.
Acción
Siemens is providing users with addendum instructions to follow during collimator change activities. This action has been closed-out on 27/01/2017.
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.