Medical device recalls
38751 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-01-19FDA-DeviceCanon Medical System, USA, INC.Class IIFlat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a workable image may remove a catheter from the patient's blood vessel and damage the blood vessel.
- 2022-01-19FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4. CUSTOM PACK BB7H95R25 HYP MAIN (Model BB7H95R25); 5. CUSTOM PACK BB7H99R22 NEONAT (Model BB7H99R22); 6. CUSTOM PACK BB7P46R4 316-14 (Model BB7P46R4); 7. CUSTOM PACK BB7P48R4 14-38 (Model BB7P48R4); 8
Product is labeled as non-pyrogenic but endotoxin testing was not performed.
- 2022-01-19FDA-DeviceDePuy Orthopaedics, Inc.Class IIGLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- 2022-01-19FDA-DeviceDePuy Orthopaedics, Inc.Class IIGLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- 2022-01-19FDA-DeviceDePuy Orthopaedics, Inc.Class IIGLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- 2022-01-19FDA-DeviceDePuy Orthopaedics, Inc.Class IIGLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- 2022-01-19FDA-DeviceDePuy Orthopaedics, Inc.Class IIGLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- 2022-01-19FDA-DeviceDePuy Orthopaedics, Inc.Class IIGLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- 2022-01-19FDA-DeviceDePuy Orthopaedics, Inc.Class IIGLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- 2022-01-19FDA-DeviceDePuy Orthopaedics, Inc.Class IIGLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- 2022-01-19FDA-DeviceOhio Medical CorporationClass IIInstavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000.
Increase in premature device failures
- 2022-01-19FDA-DevicePTW NORTH AMERICA CORPORATIONClass IISoftware BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error can occur under specific conditions. This error can lead to a too-low or too-high measured absolute dose which affects patient plan verification results
- 2022-01-19FDA-DeviceHaag-Streit USA IncClass IIOCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
- 2022-01-19FDA-DeviceHaag-Streit USA IncClass IIOCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
- 2022-01-19FDA-DevicePhilips North America LlcClass IIWireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059, 722065, 722066, 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228
Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure
- 2022-01-19FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Definition Edge -Computed tomography system Model 10590000
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
- 2022-01-19FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Edge Plus-Computed tomography system Model 1026700
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
- 2022-01-19FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Definition AS-Computed tomography system Model 8098027
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
- 2022-01-19FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Confidence -Computed tomography systems Model 10590100
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
- 2022-01-19FDA-DevicePhilips North America LlcClass IIPhilips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224
(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available
- 2022-01-19FDA-DeviceReflexion Medical, Inc.Class IIRefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS).
- 2022-01-19FDA-DeviceROi CPS LLCClass IIRegard, T AND A - Rogers, sterilized convenience kits
Kits lacks rubber latex warning label.
- 2022-01-19FDA-DeviceGetinge Usa Sales IncClass IVaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 6887700 07325710009765 Flow-e Anesthesia System 6887900 07325710010457 Flow-i Anesthesia System C20 6888520 07325710010617 Flow-i Anesthesia System C30 6888530 07325710010624 Flow-i Anesthesia System C40 6888540 07325710010631 Flow-i C20 Anesthesia System 6677200 07325710001349 Flow-i C30 Anesthesia System 6677300 07325710001349 Flow-i C40 Anes
A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) has been discovered that may result in inhalation and/or skin exposure of hydrogen fluoride.
- 2022-01-19FDA-DeviceKi Mobility LlcClass IIIKi Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport.
The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.
- 2022-01-19FDA-DeviceIon Beam Applications S.A.Class IIProteus 235; Version: PTS-8 versions before PTS-8.7.2
Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical processes in the environment is not prevented even if some processes of the test environment (tcs) are still running. It may lead to situations where the system is using test processes without notifying the clinical user. If the versions of the processes are different between both environments, this could have an impact on patient treatments.
- 2022-01-19FDA-DeviceTechnomed EuropeClass IIDisposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.
- 2022-01-12FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IIInstructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
There have been reports of stent migration.
- 2022-01-12FDA-DeviceAbbott Molecular, Inc.Class IIAlinity m System, Part No. 08N53-002
There is an issue with the installation of updated camera firmware on the system.
- 2022-01-12FDA-DeviceAbbott Molecular, Inc.Class IIAlinity m System, Part No. 08N53-002
There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
- 2022-01-12FDA-DeviceAbbott Molecular, Inc.Class IIAlinity m System, Part No. 08N53-002
There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief