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.
This recall has been terminated (originally issued September 6, 2012).
- Company
- Quality Electrodynamics Llc
- Recall Initiated
- July 27, 2012
- Posted
- September 6, 2012
- Terminated
- February 19, 2013
- Recall Number
- Z-2314-2012
- Quantity
- 17 units
- Firm Location
- Mayfield Village, OH
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution: USA (nationwide): Tennessee only and country of: Germany
Lot / Code Info
QED part numbers: Q7000057/QED000057/QSV000057 Siemens part numbers: 10606829 / 10606614 Serial #s: 1002-1012, 1016-1020, and 1022.
Root Cause
Error in labeling
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.