Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848353
Recall
- Recall Number
- Z-0303-2022
- Event Number
- 88962
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- OWB
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- October 20, 2021
- Terminated
- June 18, 2024
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418
Description
Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848353
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
Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice dated 10/202/1 to customers via AX070/21/S, Siemens will update the system software via Update Instruction AX069/21/S. Letter states reason for recall, health risk and action to take: To avoid the problem, it is recommended to position the SID first and then release x-ray. Siemens will correct the software error (software VD12) via Update Instruction AX069/21/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. We do not consider it necessary to re-examine any patients in relation to the issues described above. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein
US Nationwide Distribution
3 units