TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee t
FDA device recall Z-2314-2012 · posted 2012-09-06 · Terminated
Recall details
- Recalling firm
- Quality Electrodynamics LLC
- Reason for recall
- On July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not functional because the coil identification code for the device was incorrect.
- Action taken
- Since all of the devices were located at various Siemens distribution locations, all communications were internal to Siemens concerning bringing the coils from one warehouse to another.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MOS
- Quantity affected
- 17 units
- Distribution
- Worldwide distribution: USA (nationwide): Tennessee only and country of: Germany
- Date initiated
- 2012-07-27
- Date posted
- 2012-09-06
- Date terminated
- 2013-02-19
- Location
- Mayfield Village, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T (K082636) | Quality Electrodynamics | 2008-09-25 |