GE Precision RXi Digital Remote X-Ray Imaging R&F System. The Precision RXi digital is a remote R&F system consisting of
FDA device recall Z-1485-06 · posted 2006-09-30 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Automatic exposure control (AEC) automatically resets allowing another exposure without requiring manual reset as specified in 21 CFR 1020.31 (a)(3)(iv)
- Action taken
- Correction to devices is being implemented through GEHC Field Modification Instructions.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 83
- Distribution
- within US: CO, IL, LA, MA, MI, NC, PA, SC,TN, VA. OUS to include: Austrailia, Belgium, Burkina Faso, Brazil, Canada, China, Croatia, Czech Republic, Finland, France, Germany, Italy, Republic of Korea,
- Date initiated
- 2006-11-01
- Date posted
- 2006-09-30
- 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 |
|---|---|---|
| PRECISION RXI ANALOG X-RAY SYSTEM (K041605) | General Medical Merate S.P.A | 2004-06-30 |