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.
FDA Recall Z-2314-2012 · Posted 2012-09-06
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Recalling FirmQuality Electrodynamics LLC
Recall StatusTerminated
Product CodeMOS
Date Initiated2012-07-27
Date Terminated2013-02-19
Product Quantity17 units
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.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
Worldwide distribution: USA (nationwide): Tennessee only and country of: Germany
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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