3D TOP Ceiling Stand. X-Ray System model number 8773673
FDA device recall Z-0335-06 · posted 2005-12-31 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- screws on the rollers may become loose
- Action taken
- The recalling firm has issued a field correction per Update Instructions AX004/06/S. This update instructs a Siemens Customer Service Engineer to visit affected consignees and checkthe screws on the rollers. It also provides roller bearing sleeves as a secondary safety mechanism to prevent the rollers from detaching.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYB
- Quantity affected
- 460 units
- Distribution
- The products were shipped to hospitals and medical facilities nationwide.
- Date initiated
- 2005-11-30
- Date posted
- 2005-12-31
- 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 |
|---|---|---|
| VERTIX 3D-U (K802200) | Siemens Corp. | 1980-10-23 |