Definium AMX 700 Digital mobile x-ray system, GE Healthcare 3000 North Grandview Waukesha, WI
FDA device recall Z-0821-2007 · posted 2007-05-22 · Terminated
Recall details
- Recalling firm
- GE Medical Systems LLC
- Reason for recall
- When using the Tech Switch on exposures >750ms, >100 kVp and > 100 mAs the exposure terminates prematurely.
- Action taken
- Visit to each consignee beginning December 21, 2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 6 units
- Distribution
- Product was distributed in the following states: MS, NE, NJ, and, TX
- Date initiated
- 2006-12-21
- Date posted
- 2007-05-22
- Date terminated
- 2008-02-24
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE DEFINIUM AMX 700, MODEL AMX 700 (K052897) | General Electric Medical Systems | 2005-11-08 |