GE Precision RXi Digital remote X-Ray Imaging R&F System, model 5117828. GE Medical Systems - Americas, Milwaukee, USA T
FDA device recall Z-2145-2008 · posted 2008-09-19 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- The Precision RXi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.
- Action taken
- GE Field Engineers will visit affected customers to make correction.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 61 (32 US / 29 OUS)
- Distribution
- Within the US to include: AK, CO, IL, IN, LA, MA, MI, MS, NC, NJ, NY, PA, SC,TN, UT, VA, WA, and WI. OUS to include: Australia, Brazil, Canada, Colombia, Korea, Mexico, Philippines, Taiwan, Thailand,
- Date initiated
- 2008-05-01
- Date posted
- 2008-09-19
- Date terminated
- 2012-01-07
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRECISION RXI ANALOG X-RAY SYSTEM (K041605) | General Medical Merate S.P.A | 2004-06-30 |