December 6, 2023Medical DevicesFDA
PATH recalls SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
Hazard: Affected lots of product may experience technical distortions to a greater extent than expected.
December 6, 2023Medical DevicesFDA
PATH recalls SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
Hazard: Affected lots of product may experience technical distortions to a greater extent than expected.
December 6, 2023Medical DevicesFDA
Becton Dickinson Infusion Therapy Systems Inc. recalls BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Hazard: Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter insertion attempts, due to catheter being inadvertently removed from the insertion site.
November 29, 2023Medical DevicesFDA
LEONI CIA CABLE SYSTEMS recalls ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation
Hazard: Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again allowed after an unforeseen interruption signal of motion may result in a collision of the patient with another stationary component of the treatment room.
November 29, 2023Medical DevicesFDA
LEONI CIA CABLE SYSTEMS recalls ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation
Hazard: Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again allowed after an unforeseen interruption signal of motion may result in a collision of the patient with another stationary component of the treatment room.
November 29, 2023Medical DevicesFDA
Boston Scientific Corporation recalls EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M005
Hazard: Poor image quality due to fluid ingress in the lens.
November 29, 2023Medical DevicesFDA
Boston Scientific Corporation recalls EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
Hazard: Poor image quality due to fluid ingress in the lens.
November 29, 2023Medical DevicesFDA
Philips North America Llc recalls SmartPath to dStream for 1.5T
Hazard: Potential component failure in the Gradient Coil could product smoke and/or fire.
November 29, 2023Medical DevicesFDA
Philips North America Llc recalls Intera 1.5T Power/Pulsar
Hazard: Potential component failure in the Gradient Coil could product smoke and/or fire.
November 29, 2023Medical DevicesFDA
Philips North America Llc recalls Intera 1.5T
Hazard: Potential component failure in the Gradient Coil could product smoke and/or fire.
November 29, 2023Medical DevicesFDA
Philips North America Llc recalls Ingenia 1.5T CX
Hazard: Potential component failure in the Gradient Coil could product smoke and/or fire.
November 29, 2023Medical DevicesFDA
Philips North America Llc recalls Achieva 1.5T Initial System
Hazard: Potential component failure in the Gradient Coil could product smoke and/or fire.
November 29, 2023Medical DevicesFDA
Philips North America Llc recalls Achieva 1.5T Conversion
Hazard: Potential component failure in the Gradient Coil could product smoke and/or fire.
November 29, 2023Medical DevicesFDA
Philips North America Llc recalls Achieva 1.5T
Hazard: Potential component failure in the Gradient Coil could product smoke and/or fire.
November 29, 2023Medical DevicesFDA
Biomet, Inc. recalls Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous
Hazard: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
November 29, 2023Medical DevicesFDA
Biomet, Inc. recalls Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous
Hazard: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
November 29, 2023Medical DevicesFDA
Biomet, Inc. recalls Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous
Hazard: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
November 29, 2023Medical DevicesFDA
Biomet, Inc. recalls Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous
Hazard: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
November 29, 2023Medical DevicesFDA
Biomet, Inc. recalls Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous
Hazard: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
November 29, 2023Medical DevicesFDA
Biomet, Inc. recalls Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous
Hazard: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
November 29, 2023Medical DevicesFDA
Biomet, Inc. recalls Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous
Hazard: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
November 29, 2023Medical DevicesFDA
Biomet, Inc. recalls Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous jo
Hazard: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
November 29, 2023Medical DevicesFDA
Biomet, Inc. recalls Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous
Hazard: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
November 29, 2023Medical DevicesFDA
Biomet, Inc. recalls Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous
Hazard: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
November 29, 2023Medical DevicesFDA
Biomet, Inc. recalls Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesis, or previous join
Hazard: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
November 29, 2023Medical DevicesFDA
Biomet, Inc. recalls Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ
Hazard: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
November 29, 2023Medical DevicesFDA
Biomet, Inc. recalls Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ
Hazard: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
November 29, 2023Medical DevicesFDA
Biomet, Inc. recalls Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ
Hazard: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
November 29, 2023Medical DevicesFDA
Biomet, Inc. recalls Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ
Hazard: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
November 29, 2023Medical DevicesFDA
Biomet, Inc. recalls Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ
Hazard: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery