Siremobil Compact Mobile X-Ray System
FDA device recall Z-0120-06 · posted 2005-11-02 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Screws may become loose and fall into the OR field during surgery.
- Action taken
- The recalling firm has their Service Engineers visiting each site to check the screws on the window and secure them with Loctite per Update Instructions SP022/05/S. The Service Engineer is also informing the account of the problem during the visits.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 1 unit
- Distribution
- The products were shipped nationwide to a distributor, a physician, and medical facilities
- Date initiated
- 2005-08-01
- Date posted
- 2005-11-02
- Date terminated
- 2006-07-19
- 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 |
|---|---|---|
| SIREMOBIL COMPACT (K963093) | Siemens Medical Solutions USA, Inc. | 1996-09-03 |