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 have identified an intermittent communication issue between the host system and the flex cardio (fc). it is possible for any of the following conditions to occur, which could result in delays in diagnosis or treatment:- boom monitor may not display all active waveform and/or vital sign data- delayed audible and visual alarms at the fc and boom monitor respectively, due to a mismatch between the alarm limits on the host system and the fc/boom monitor- after patient admission and case initiation at the host system, the case may not be fully transmitted to the fc. in this case, the boom monitor in the exam/procedure room will display vital sign data, but the fc will not provide audible alarms- after patient discharge and case termination at the host system, case termination may not be transmitted to the fc. in this case, the boom monitor in the exam/procedure room will continue to display vital sign data, and the fc will continue to provide audible alarms.
Acción
Philips are advising the following to reduce the probability of intermittent communication issues:
- The Flex Cardio must communicate with its host system via an isolated, dedicated Ethernet port
- Do not turn the Flex Cardio device on and/or off while a patient case is open
- Verify that the patient name is visible on the Boom Monitor, which is an indication that the patient case has fully transferred and audible alarms are active. Also, if all expected vital signs are not displayed on the Boom Monitor, close and then re-open the case to resynchronize the Flex Cardio and the host system.
An addendum to the device’s Instructions for Use will be provided to all affected customers by a Philips representative. Philips will also review the contents of the Instructions for Use addendum with each customer and confirm understanding of the addendum’s contents. Affected customers will also be provided with an updated Software and Documentation Media Kit, which contains the IFU addendum.
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
Medtronic has identified that the irrigation pin used to manufacture (moulding) the hub outer tube was incorrectly placed in the mould. the use of a shorter pin resulted in blockage of the irrigation lumen of specific straightshot microdebrider blades.To date, there have been no reported injuries as a result of this issue.
Acción
Medtronic is advising customers to cease use of affected product. Customers are requested to return unused units by following the instructions outlined in the Customer Letter.
Medtronic is advising clinicians who may have used impacted units to monitor their patient's condition to determine if there are any signs of infection. If infection is present, the patient should seek medical attention immediately for treatment.
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
Medtronic has identified the potential for the device to have a misassembled (reversed) sled component. the sled component is responsible for staple deployment. when the device is applied to tissue and fired, a misassembled sled may result in the tissue being transected without the deployment of staples to seal the point of transection. this may result in bleeding, immediate anastomotic leak, and/or the potential for death if this is used on a critical vascular structure such as the pulmonary artery and renal artery. internationally, medtronic have received one report of injury related to this issue. to date, there have been no reported injuries in australia.
Acción
Medtronic is advising customers to immediately discontinue use of the affected products. Unused product should be quarantined and returned to Medtronic by following the instructions outlined on the Customer Letter. Medtronic will arrange collection of stock from customers and issue a credit for returned goods.
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 biomet has received an overseas complaint regarding the segmental proximal femoral body 38mm offset alleging that the hole on the superior lateral aspect contained debris. an investigation determined that the debris was from the machining process that was not adequately removed during the subsequent cleaning process.To date, no adverse events have been reported as a result of this issue.
Acción
Zimmer Bioment are advising Surgeons to maintain awareness of this issue, however, there are no specific patient monitoring instructions beyond the existing follow-up schedule for patients who have been implanted with these units.
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
During a dbs lead implant procedure, the fhc depth stop adapter is placed onto the lead to set the desired distance to target. the depth stop adapter then mounts in the lead measurement fixture to ensure that the lead is not inserted beyond the targeted depth. the fhc depth stop adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. this damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperatively or in a follow-up procedure. recent reports of lead short circuit events have led to an improvement of the depth stop design and a recall the previous version of this product. to date, there have been no reports of patient death related to this problem.
Acción
Emergo is advising FHC and Medtronic Field Representatives will review user's inventory and replace affected Depth Stop Adapters on hand with an improved design.
In the interim, Emergo advise that users do not over-tighten the Depth Stop Adapter screw. If low impedances or a short circuit is found, physicians should replace the lead prior to use and report the issue to FHC, Emergo Australia, or their local field rep.
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
Baxter healthcare has identified an issue with the use of an incorrect plastic formulation in the manufacture of the blue luer component of the floseal malleable tips. the plastic formulation does not present any toxicity or biocompatibility concerns, but does impact the physical characteristics of the blue luer component. the affected lots of the floseal malleable applicator tip have been associated with the cracking of the luer upon connection with the syringe. since the tip is attached to the syringe outside of the surgical field, it is unlikely that plastic fragments would reach the surgical field. nevertheless, in exceptional cases, detached subvisible particles may be retained in the body and may cause inflammation, or serve as a nidus for bacteria in already contaminated wounds and contribute to allergic reactions. to date, there have been no reports of serious injury associated with this issue.
Acción
Baxter is advising customers to locate and return all units of the affected product. Instructions for return can be found on 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
Bio-rad have identified that certain lots of mrsaselect ii agar may have abnormal colouration and growth of non-characteristic mrsa colonies.If plates were exposed to light but none defects have been detected before use, then mrsa colonies may appear white to yellow instead of the pink characteristic colour, or the growth may be delayed. as a result, there is a risk of misinterpretation of the result.
Acción
Bio-Rad is advising:
- For the references and batches of affected product, do not expose the boxes more than 4 hours to light during the intermediate storage steps, including returning at room temperature, and during incubation until the reading step.
- Do not use a suspicious colour agar.
- As recommended in the package insert, if in doubt, confirm the identification of colonies by coagulase test or Pastorex Staph Plus.
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 issues have been identified with the samsung digital x-ray system gc80:1. if the user does not completely close the detector tray in the table or stand, the system turns into the portable mode or the multi-portable mode and auto exposure control (aec) turns off. at this time, the screen of workstation and the screen of tube head unit (thu) show the portable mode on or the multi portable mode on and aec off. if the user makes an exposure without checking, it may be irradiated differently than intended and produce an unintended image.2. if the user incorrectly attempts to use a portable detector within the table detector or stand detector areas with the auto detector option switched on, the system may automatically select the table or stand detectors if the focal spot is met. in this situation, if the user attempts an exposure of the portable detector without checking which detector is selected, it may be irradiated differently than intended and produce an unintended image.
Acción
Samsung is advising users:
1. Carefully close the detector tray and check that the detector tray is completely closed.
2. When using a portable detector:
a. ensure the portable detector is placed outside the table detector or stand detector area when the auto detector option is switched on; or
b. switch off the auto detector option before exposing patients with a portable detector placed within the table or stand detector areas.
3. Always carefully check the screen of Workstation or the screen of THU before making an exposure, and be sure to check the Receptor (4), AEC mode (7,8), and the exposure condition (1,2,3,5,6,9,10,11,12).
If the intended detector is not set, please select the detector to be used.
Samsung is planning to release updated software (expected to be available 30 June 2018) to prevent the outlined issues occurring. Implementation of the software update will be carried out by Quantum Healthcare Pty Ltd.
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 have identified that when the operator or a bystander touches the area of the inner part of the vertical sliding column (on which the tube arm moves up or down), without paying attention of the tube arm movement, the operator's fingers can be pinched.
Acción
Philips are advising that they will install a new label on affected systems. A Philips Service Engineer will contact customers when the Field Action Kit is available to be implemented.
In the interim, customers may continue to use their systems, provided they follow the Instructions for Use which outlines that users keep all body parts and clothing free of the equipment to avoid getting caught or trapped within the moving components.
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
Bio-rad have observed that the values for blood and ketones may gradually decrease, and values for ph may gradually increase over the shelf life of affected product lots. this issue is not expected to impact patient results.
Acción
Bio-Rad is advising users that the package insert has been updated to specify the changing values for these analytes.
Laboratory means and acceptable ranges may need to be re-established for Blood, Ketones and pH during the shelf life of the product.
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 biomet has identified that specific serial numbers of dermatome an may have a loose control bar which could compromise the ability to control the thickness of the graft. the affected devices could also potentially have a loose width plate that if undetected, could result in an imperfect, yet still usable graft.
Acción
Zimmer Biomet is advising customers to immediately inspect stock and quarantine affected product. A Zimmer sales rep will contact sites to arrange return and replacement with an unaffected batch.
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
Baxter healthcare have identified the potential for a leak to occur at the tube to cap junction of the in-line blood set with filter (mmc2433). preliminary investigation has shown that this issue is due to the combination of cap dimension variability, especially on lower limit, and insertion depth of the cap into the tube on the lower side.To date, no complaints have been received as a result of this issue.
Acción
Baxter is advising customers to identify and quarantine affected product from their facility. Baxter will arrange return of product from impacted users.
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 current packaging and ifu indicate a five-year shelf life. during long-term product testing, it was discovered that after a three-year term, there is a potential for the external packaging (sterile barrier) to become compromised. such compromised packaging results in the loss of the vacuum seal allowing for contamination of the inside peel pouch. a breach of the outer peel pouch has only been observed with packages at shelf life end and after excessive transportation testing.To date, medtronic have not received any complaints as a result of this issue.
Acción
Stryker is advising customers to quarantine affected stock to prevent further use. Stryker representatives will contact customers to help coordinate the return of any affected product.
In the event this device has been recently implanted, surgeons are advised to monitor for signs of infection as per their normal processes.
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
Ge healthcare has identified that the latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. if the incorrect version is loaded on the system, the images can be flipped left/right and/or there can be patient data mismatch.
Acción
GE Healthcare are advising they will inspect all affected systems and ensure the proper software version is installed. GE Healthcare will check systems remotely (on-line) where possible, and will visit sites if a remote check is not possible.
GE Healthcare will advise users after the software version has been inspected and if any correction is needed. If a correction is needed, a service representative will contact users to arrange for this correction.
Users may refer to the information in the Customer Letter to check their system software version. If an impacted system is identified, users are advised to contact their GE representative immediately
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
Starkey have been made aware of a single incident in the uk where an unattended child aged 7 months has required treatment to remove an earmould from the larynx. this is the first reported incident of its kind, the likelihood of such event is considered extremely low and on this occasion there was no long-term injury.There have been no reported incidents in australia relating to this issue.
Acción
Starkey is recommending clinicians glue tubing in place for new mould orders manufactured for children up to the age of 36 months. Clinicians are advised to mark orders with "Glue-inTube" when patients meet this criterion.
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
Emergo have identified the potential for the tethered plug on the hub inadvertently opening after closure. the tethered plug not staying closed in the feeding tube hub may result in a leak of nutrition from the feeding tube. as described in the instructions for use (ifu) provided with the product, sterile water should be the only liquid that would leak from the feeding tube when the user flushes the tube before and after use. to date, no adverse events related to this issue have been reported to neomed.
Acción
Emergo is requesting that users examine their inventory for product subject to this recall and quarantine all affecetd stock until a return can be facilitated as per the instructions given 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
It has been identified by emergo that some raystation/rayplan users have commissioned machines with erroneous beam profile correction parameters. these parameters affect the dose calculated in corners of large or off-axis fields. to the best of our knowledge, the issue has not caused any patient mistreatment.
Acción
Emergo is requesting that users:
Always validate the beam model for all clinically relevant fields, including, but not limited to, large and off-axis fields, before the system is used to create clinical treatment plans.
- Carefully review all beam model parameters before commissioning.
- Be aware that the Beam profile correction values may need to be adjusted in order to correctly model the primary collimator that limits the dose in the corners of large or off-axis fields.
- Review any existing photon beam models to ensure that the actions above have been properly performed.
Please educate physics staff about these user responsibilities.
Inspect your product and identify all installed units with the above software version number(s), then confirm that you have read and understood this notice by replying to the notification email.
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 has discovered that specific lots of the mako rio system irrigation clip have the potential to fracture. the rio system irrigation clip is a sterile disposable, used to direct saline flow for the burring tool during a mako partial knee surgery. in the event of a break in the mako rio system irrigation clip, potential hazards of a fractured device and/or foreign object (inert particulate left in wound) may occur.
Acción
Stryker is advising customers to inspect inventory and quarantine affected product, Stryker will contact customers to arrange return of affected product.
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 bd alaris infusion pump administration sets require priming prior to use as described in the directions for use (dfu). bd has identified a potential issue with the bd alaris infusion pump administration sets manufactured during january 2017 through march 2018. the issue pertains to the back check valve and the ability to prime the administration sets. the manufacturer has determined the root causes leading to this issue are associated with: 1. excessive solvent used to connect the tubing to the back check valve leading to an obstruction of the fluid path, thus preventing the priming of the set. 2. a higher “cracking” pressure of the back check valve.To date, no injuries have been reported as a result of this issue.
Acción
CareFusion is advising that users can continue to use the product.
When a set cannot be appropriately primed, users may be able to increase the pressure by gently squeezing the IV bag following these steps:
1. If no drops are observed, gently squeeze the bag at the fluid level with one hand once. Observe if set is able to prime.
2. If no drops are observed repeat this up to 3 times.
3. If this method is not effective discard and replace the administration set.
4. Consider having additional administration sets available in clinical areas where high risk infusions are administered.
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 small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. to date, no injury has been reported to ge as a result of this issue.
Acción
GE is advising they will be in contact with users to arrnage for impacted products to be corrected.
In the interim, users may continue to use the system by following the existing Operator Manual Safety Information for proper patient padding and observation during scanning.
If a brown discolouration is seen on the inner surface of the patient bore, or if a burning smell is noticed, please contact the local GE Service Representative.
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
Device technologies has been notified by the manufacturer, symmetry surgical, of a product complaint regarding a monopolar pencil and cord. the reporting site observed some anomalies in the packaging seal resulting from the package’s contents having migrated near or within the seal area. this condition increases the risk of the seal’s integrity being compromised. testing indicated that the defect is introduced during the packaging operation and will not result from shipping or normal handling conditions.
Acción
Device Technologies (DTA) is advising customers product is acceptable for use if it is visually confirmed that the package's contents do not interfere with the packaging seal and the seal is intact.
Users are advised to either:
- Inspect all affected product in accordance with the inspection instructions outlined in the Customer Letter. Product that does not meet acceptance criteria should be shipped back to DTA for credit. If users are uncertain if product is acceptable it is advised to return the item; OR
- Ship stock held of the Olsen Single Use Electrocautery Forceps/Pencils/Cords back to DTA for credit.
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 have identified that the product visionaire lightweight alignment rod is oversized, preventing mating with the visionaire alignment connector.
Acción
Once the recall acknowledgement has been received and there is product to be retrieved, a Smith & Nephew Representative will go to the hospital to retrieve the affected items are provide replacement products
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
Nxstage has identified a potential risk of electrical fire, in the event fluid leaks into the power receptacle on the back of the express fluid warmer. this risk exists at any time whilst the warmer is plugged in. nxstage has received 7 reports of smoke, sparks or flames coming from the express fluid warmer since 2016. there have been no adverse health consequences or medical interventions reported as a result of this issue.Given the occurrence of these incidents, the instructions for use (ifu) are being updated with a warning about fluid bags and fluid near the warmer, along with instructions on how to minimise this risk.
Acción
NxStage, through Regional Health Care Group have taken the decision to
replace the Instructions for Use with an updated IFU.
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
Ge has been made aware when multiple carescape monitor b650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. the monitor restart will not be completed until the network issue has been corrected. loss of overall monitoring for a prolonged time may lead to a delay in detection of permanent or irreversible impairment or life-threatening changes in the condition of the patient.To date, ge has not received reports of injury as a result of the reboot process.
Acción
GE Healthcare is advising that they will in contact with users to arrange correction of affected products.
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 there can be a 2mm +/- overall length difference between various manufacturers pp3 batteries that could be used in niki t34 ambulatory syringe pumps. this could result in movement within the battery housing leading to a possible loss of connection, resulting in the pump powering down and a possible under infusion of pain medication occurring.
Acción
If a battery within the NIKI T34 housing appears loose, careful adjustment of the battery connections may be required as detailed in the Customer letter