Recall Z-1001-2023 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Siemens Medical Solutions USA, Inc
AXIOM Luminos Agile
| Date | Jan 20, 2023 (initiated Dec 9, 2022) |
| Status | Open, Classified |
| Reason | There is potential for the footrest to detach from the patient table during use. |
| Root cause | Process control |
| Action | A Customer Safety Advisory Notification (CSAN) was distributed to affected consignees beginning December 9, 2022. The CSAN was distributed to inform the customers about a preventative measure to exclude any potential risk of patient injury caused by the footrest detaching from the patient table during examination. Together with the CSAN, an addendum to the operator manual is distributed containing additional details and illustrations on how to securely attach the footrest to further improve the understanding of handling the footrest. Refer to the CSAN with addendum and copies of the Instructio |
| Quantity | 271 units |
| Distribution | Worldwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111292 | LUMINOS AGILE Siemens Medical Solutions USA, Inc., Jun 3, 2011 |