Recall Z-1311-2023 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.
| Date | Mar 30, 2023 (initiated Feb 2, 2023) |
| Status | Open, Classified |
| Reason | In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment. |
| Root cause | Software design |
| Action | Siemens Healthcare issued A Customer Safety Advisory Notice distributed to customers on 2/2/23 via AX041/22/S. A software update to correct the error will be distributed to all affected customers via Update Instructions AX040/22/S. Affected systems will be updated to SW version VE10B. Letter states reason for recall, health risk and action to take: Please perform system movements with adequate care to avoid injuries to persons and damage to equipment due to collisions or crushing. Siemens will correct the software error via Update Instructions AX040/22/S. Our service organization will contac |
| Quantity | 141 units US |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163286 | ARTIS pheno Siemens Medical Solution USA, Inc., Mar 9, 2017 |