GE Precision MPi, model 2385125. GE Medical Systems - Americas, Milwaukee, USA The product is used to generate radiograp
FDA device recall Z-2143-2008 · posted 2008-09-19 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- The Precision MPi 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 visited affected customers to make the correction.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 54 (24 US / 30 OUS)
- Distribution
- Within the US to include: CA, CO, FL, IN, MA, MN, NV, NY, OR, PA, TN, VT, WA, and WI. OUS to include: CANADA, GERMANY, ITALY, POLAND, SAUDI ARABIA, SLOVAKIA, SPAIN, TURKEY, and UNITED KINGDOM,
- Date initiated
- 2008-05-01
- Date posted
- 2008-09-19
- Date terminated
- 2011-12-17
- 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 |
|---|---|---|
| GE PRECISION MPI (K033486) | Nrt-Nordisk Rontgen Teknik A/S | 2003-11-19 |