Z-0298-2022 Class II Terminated
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
- 19 units
Product Description
Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094139
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: 159030 159034 159038 159032 159046 159054 159015 159058 159028 159037 159026 159042 159047 159025 159024 159021 159041 159049 159010 Expanded Recall 11/15/21: 159065