GE Healthcare Definium 8000 Digital Radiographic System, model number 5135678. GE Healthcare, 3000 North Grandview, Wauk
FDA device recall Z-1883-2008 · posted 2008-09-25 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Not properly labeling the manual switch for disabling positive beam limitation (PBL) located on the overhead tube support user interface as required
- Action taken
- GE Field Engineer will visit each site to implement the correct label. Contact GE Healthcare at 1-262-544-3894 for assistance.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 668 (419 US / 249 OUS)
- Distribution
- AL, CA, CO, CT, DE, FL, GA, IA,, IL,, IN, KS, LA, MA, MD, MI, MN, MO, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI,WV and Washington D.C. OUS to include: Australia, Austria,
- Date initiated
- 2008-01-02
- Date posted
- 2008-09-25
- Date terminated
- 2011-12-10
- 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 |
|---|---|---|
| REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS (K051967) | GE Healthcare | 2005-08-09 |