AXIOM Luminos Agile
FDA device recall Z-1001-2023 · posted 2023-01-20 · Open, Classified
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- There is potential for the footrest to detach from the patient table during use.
- Action taken
- 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 Instructions for Use for each reported system.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- JAA
- Quantity affected
- 271 units
- Distribution
- Worldwide distribution
- Date initiated
- 2022-12-09
- Date posted
- 2023-01-20
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LUMINOS AGILE (K111292) | Siemens Medical Solutions USA, Inc. | 2011-06-03 |