Medical device recalls
39137 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-12-21FDA-DeviceSiemens Medical Solutions USA, IncClass IIARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter
- 2022-12-21FDA-DeviceZimmer, Inc.Class IINexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02
Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.
- 2022-12-21FDA-DeviceZimmer, Inc.Class IINexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01
Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.
- 2022-12-21FDA-DeviceZimmer, Inc.Class IINexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02
Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.
- 2022-12-21FDA-DeviceZimmer, Inc.Class IINexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01
Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.
- 2022-12-21FDA-DeviceZimmer, Inc.Class IINexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02
Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.
- 2022-12-21FDA-DeviceZimmer, Inc.Class IINexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- 2022-12-21FDA-DeviceARROW INTERNATIONAL Inc.Class IArrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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