All Recalls

95,050 total recalls in our database

AXIOM Artis dBA, Model Number 7555357

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

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.

Jun 12, 2019 Other Medical Devices Nationwide View Details →

AXIOM Artis dFA, Model Number 7555373

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

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.

Jun 12, 2019 Other Medical Devices Nationwide View Details →

Artis zee floor, Model Number 10094135

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

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.

Jun 12, 2019 Other Medical Devices Nationwide View Details →

An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.

May 16, 2018 Diagnostic Equipment Nationwide View Details →

AXIOM Artis dTA, Model Number 7008605

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

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.

Jun 12, 2019 Other Medical Devices Nationwide View Details →

An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.

May 16, 2018 Diagnostic Equipment Nationwide View Details →

Artis zee biplane, Model Number 10094141

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

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.

Jun 12, 2019 Other Medical Devices Nationwide View Details →

An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.

May 16, 2018 Diagnostic Equipment Nationwide View Details →

Artis zeego, Model Number 10280959

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

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.

Jun 12, 2019 Other Medical Devices Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).

Jul 11, 2019 Other Medical Devices Nationwide View Details →

An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.

May 16, 2018 Diagnostic Equipment Nationwide View Details →