GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examinat
FDA device recall Z-2221-2012 · posted 2012-08-17 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- X-ray units did not meet manufacturer's specification for linearity.
- Action taken
- GE updated their user manual and changed their internal specifications to match those of the CFR In addition, a software code correction was to be made to forward productions in order to correct the reported defect. *** This recall issued was previously classified under an incorrect recall number. It is being reclassified with a new number. ***
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 175 units
- Distribution
- Worldwide Distribution - USA - Australia, Brazil, Cameroon, China, Colombia, Cyprus, The Czech Republic, Finland, France, Germany, Greece, Italy, Japan, Korea, Malaysia, The Netherlands, New Zealand,
- Date initiated
- 2007-10-19
- Date posted
- 2012-08-17
- Date terminated
- 2012-08-17
- 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 |
|---|---|---|
| FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM (K003837) | Ge Oec Medical Systems | 2001-03-12 |