Mobilett XP, mobile X-ray system, Model number 1818454
FDA device recall Z-0749-2007 · posted 2007-04-19 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Mounting bolts for tank fork assembly and collimator flange may become loose.
- Action taken
- Siemens Service Personnel are visiting each consignee, beginning March 21, 2007, to replace the required mounting bolts and tighten them according to required torque specifications.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 186 units
- Distribution
- The products were shipped to medical facilities nationwide.
- Date initiated
- 2007-03-21
- Date posted
- 2007-04-19
- Date terminated
- 2007-08-07
- 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 |
|---|---|---|
| MOBILETTE XP AND MOBILETT XPHYBRID (K033238) | Siemens Medical Systems, Inc. | 2003-11-14 |