FDA Recall
Terminated
TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician.
Recall: Z-2314-2012
·
Initiated July 27, 2012
Recall
- Recall Number
- Z-2314-2012
- Event Number
- 62949
- Firm
- Quality Electrodynamics LLC
- FEI Number
- 3007350713
- Product Code
- MOS
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- July 27, 2012
- Posted
- September 6, 2012
- Terminated
- February 19, 2013
- Address
- 700 Beta Dr, Ste 100, Mayfield Village, OH, 44143-2378
Description
TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician.
Reason
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
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.
Distribution
Worldwide distribution: USA (nationwide): Tennessee only and country of: Germany
Quantity
17 units