Z-0296-2022 Class II Terminated
FDA device recall Z-0296-2022 was initiated by Siemens Medical Solutions USA, Inc on October 20, 2021 and is designated Class II. Reason for recall: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short d… The recall status is terminated (terminated June 18, 2024). Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 1, 2021
- Initiation Date
- October 20, 2021
- Termination Date
- June 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135
Reason for Recall
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
Distribution Pattern
US Nationwide Distribution
Code Information
Serial Numbers: 124703 139012 139023