FDAFDA · Food and drugs·Recall number Z-2314-2012
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.
Published September 12, 2012 · Recall initiated: July 27, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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 to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Quality Electrodynamics LLC
- Distributor
- Worldwide distribution: USA (nationwide): Tennessee only and country of: Germany
- Lot
- QED part numbers: Q7000057/QED000057/QSV000057 Siemens part numbers: 10606829 / 10606614 Serial #s: 1002-1012, 1016-1020, and 1022.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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