Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-08-29FDA-DeviceGE Healthcare Japan CorporationClass IIGE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold under the following product names: CT GOLDSEAL LIGHTSPEED ULTRA, CT OPTIMA 660, CT OPTIMA 660 M40 3.5 LONG BJG, CT OPTIMA 660 M40 GT1700, CT OPTIMA 660 M40 GT1700 BEIJI, CT OPTIMA 660 M40 GT1700 HINO, CT OPTIMA 660 M40 GT2000 BEIJI, CT OPTIMA 660 M40 GT2000 HINO, CT OPTIMA CT 660, CT OPTIMA CT660, CT OPTIMA CT
GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
- 2018-08-29FDA-DeviceBecton Dickinson & Co.Class IIBD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neisseria gonorrhoeae and better inhibition of contamination bacteria and fungi.
A portion of this lot was manufactured using Gentamicin instead of Vancomycin. Gentamicin is an inhibitory agent of Neisseria organisms. This product is a selective plated medium to provide enhanced growth and recovery of N gonorrhoeae. Inhibited growth may cause a false negative result or a delayed result leading to incorrect or delayed treatment.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIEasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIEasyDiagnost Eleva DRF (Stitching Patient Support) 706032
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost, Single-Detect (Stitching Patient Support) 712062
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost Upgrades (Stitching Patient Support) 712083
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost Single Detector (Stitching Patient Support) 712020
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost Release 3 (Stitching Patient Support) 712025
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost Dual Detector (Stitching Patient Support) 712022
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost Dual Detector (Stitching Patient Support) 712022
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost 4.1 (Stitching Patient Support) 712225
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost 4 High Performance (Stitching Patient Support) 712027
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IICombiDiagnost R90 (Stitching Patient Support) 709030
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIBuckyDiagnost Ceiling System (Stitching Patient Support) 704031
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost Release 3 (Stitching Patient Support) 712025
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
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