U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
DePuy ASR 100 Acetabular Implant, 64 mm - Product Code KWA
Causa
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Mckesson has identified a potential hardware configuration problem in some horizon cardiology hemo systems which may cause delay and/or loss of the patient's physiological parameters on the horizon cardiology hemo screen and on the patient record.
Acción
The firm, McKesson Israel Ltd., sent notification letter dated January 27, 2010 to customers. The letter describes the product, problem and action to be taken by customers and the firm. McKesson's will be contacting the customer to coordinate replacement of the sound component of the Horizon Cardiology Hemo system and will provide the additional sound adapter for all affected systems at your facility at not cost. The customers were instructed to pleasel immediately conduct the following instructions to disable sound operations-1) Open McKesson Management Console and locate the Windsurfer>Monitor Settings; 2) Uncheck "Enable QRS beep" in the sounds section; 3) Locate Windsufer>Hardware Settings in McKesson Management Console, and 4) Uncheck "Enable QRS beep" in the Analog Output, QRS Beep Section.
If you have any questions, please do not hesitate to contact Ronen Gans directly at (973) 355-9900.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notification to clinicians of new revision rate data/information regarding the use of the device. as part of the post-market surveillance, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. as part of the post-m.
Acción
DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The k302 relay switch of the g3 series aed product line may experience an early failure. if the k302 contacts are open at the time of rescue, there is a possible delay in therapy or failure to deliver therapy.
Acción
Customer notification letters were mailed to US end users and distributors (final consignees) between December 18 and 23, 2009 by USPS certified mail, return receipt requested.
Notification letters were sent by FedEx to Canadian distributors (final consignees) on December 23, 2009.
Secondary consignee (distributor) letters were mailed on December 23, 2009.
Letters advise user to check the status indicator on front of AED to determine if it is rescue ready. Users are advised to keep the AED in service and to perform the Daily and Monthly Scheduled Maintenance as outlined in the Operator and Service Manual.
Questions about this communication should be addressed to 1.877.901.1788 toll free from inside the US, or to email .
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Reduced sensitivity in the force measurement sensor can result in inaccurate feedback to the user on how well he or she is releasing pressure after each chest compression. this can result in incomplete release of chest compression, which will reduce cpr effectiveness.
Acción
Philips issued an "Urgent Medical Device Recall notification/Field Safety Notice" dated April 2010 to all consignees. The letter described the issue, how to identify affected devices, and required actions. The consignees were instructed to remove affected devices from service. Philips will contact consignees to arrange on-site replacement of affected meters with meters containing revised labeling and calibration software. The new meters will indicate that meter recalibration is required after approximately 50,000 compression cycles. Consignees returning devices to Philips for routine recalibration will receive free replacement. All CPR meters will be replaced with re-designed meters when they become available.
For questions or assistance in notifying accounts about this recall, contact Philips at 1-800-722-9377.