Z-2314-2012 Class II Terminated
FDA device recall Z-2314-2012 was initiated by Quality Electrodynamics LLC on July 27, 2012 and is designated Class II. 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. The recall status is terminated (terminated February 19, 2013). Affected quantity: 17 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 12, 2012
- Initiation Date
- July 27, 2012
- Termination Date
- February 19, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 units
Product 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 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 Pattern
Worldwide distribution: USA (nationwide): Tennessee only and country of: Germany
Code Information
QED part numbers: Q7000057/QED000057/QSV000057 Siemens part numbers: 10606829 / 10606614 Serial #s: 1002-1012, 1016-1020, and 1022.