FDA Device

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.

Hazard

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.

What You Should Do

Remedy

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.

Products

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.
Brand
Quality Electrodynamics LLC
UPC
QED part numbers: Q7000057/QED000057/QSV000057 Siemens part numbers: 10606829 / 10606614  Serial #s: 1002-1012, 1016-1020, and 1022.

Units Affected

17 units