Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIArtis zee biplane MN, Model Number 10094143
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIArtis zee floor MN, Model Number 10094142
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIArtis zee biplane, Model Number 10094141
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIArtis zee multi, Model Number 10094139
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIArtis zee ceiling, Model Number 10094137
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIArtis zee floor, Model Number 10094135
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM Artis dBC, Model Number 7728392
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM Artis TC, Model Number 7728350
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM Artis dFC, Model Number 7727717
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM Artis dFA, Model Number 7555373
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM Artis dMP, Model Number 7555365
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM Artis dBA, Model Number 7555357
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM Artis dTC, Model Number 7413078
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM Artis dFC, Model Number 7412807
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM Artis dTA, Model Number 7008605
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM Artis TA, Model Number 7007755
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM Artis dBC, Model Number 5917054
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM Artis BA, Model Number 5904656
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM Artis BC, Model Number 5904649
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM Artis MP, Model Number 5904466
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM Artis FA, Model Number 5904441
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DeviceSiemens Medical Solutions USA, IncClass IIAXIOM Artis FC, Model Number 5904433
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- 2019-07-31FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIBrightView XCT , Model Number 882482
An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
- 2019-07-31FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIBrightView X , Model Number 882478
An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
- 2019-07-31FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIBrightView SPECT, Model Number 882480
An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
- 2019-07-31FDA-DeviceBecton Dickinson & CompanyClass II3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061
The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.
- 2019-07-31FDA-DeviceBecton Dickinson & CompanyClass II3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573
The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.
- 2019-07-31FDA-DeviceTerumo Medical CorporationClass IITerumo Needle, 30G x 1/2", Product Code NN3013R
There is a potential for a loss of package integrity that may compromise the sterility of the product.
- 2019-07-31FDA-DeviceTerumo Medical CorporationClass IITerumo Needle, 23G x 1", Product Code NN2325R
There is a potential for a loss of package integrity that may compromise the sterility of the product.
- 2019-07-31FDA-DeviceTerumo Medical CorporationClass IITerumo Needle, 18G x 1", Product Code NN1825R
There is a potential for a loss of package integrity that may compromise the sterility of the product.
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