OEC Miniview 6800 mobile fluoroscopic x-ray system, GE Healthcare, Surgery, Salt Lake City, Utah.
FDA device recall Z-0928-2007 · posted 2007-07-03 · Terminated
Recall details
- Recalling firm
- OEC Medical Systems, Inc
- Reason for recall
- X-ray systems did not have the required labeling to indicate Air Kerma Rate and cumulative Air Kerma during fluoroscopic procedures
- Action taken
- Consignees were notified by letter on 05/24/2007 and advised that a service representative would be contacting them for installation of the required label and to provide them with an update to their user's manuals.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 811 systems
- Distribution
- Worldwide; USA including VA facilities in AK, CA, ID, MD, MI, NY and OR. Military distribution to CA, CO, CT, FL, GA, KS, LA, MS, OH, OK, TX, VA and Iraq. Foreign distribution to Austria, Australia, B
- Date initiated
- 2007-05-24
- Date posted
- 2007-07-03
- Date terminated
- 2008-06-02
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MINI 6800 DIGITAL MOBILE C-ARM (K992506) | Ge Dec Medical Systems | 1999-08-19 |