Siemens Medical Solutions USA, Inc Recall 88962
Description: Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354
Siemens Medical Solutions USA, Inc Recall 88962 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0304-2022 |
| Event ID | 88962 |
| Event Description | Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354 |
| Product Type | Devices |
| Distribution | US Nationwide Distribution |
| Quantity | 15 units |
| Recall Reason | 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 |
| Device Classification | 20211201 |
| Device Code Info | Serial Numbers: Serial 111502 111503 111510 111507 111512 111508 111133 111504 111506 111513 111500 111501 111505 111514 |
| Center Classification Date | 20211124 |
| Recall Initiation Date | 20211020 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
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