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U.S. Department of Health and Human Services

Class 2 Device Recall TxRx Knee 15 Coil 3T

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 Class 2 Device Recall TxRx Knee 15 Coil 3Tsee related information
Date Initiated by FirmJuly 27, 2012
Date PostedSeptember 06, 2012
Recall Status1 Terminated 3 on February 19, 2013
Recall NumberZ-2314-2012
Recall Event ID 62949
510(K)NumberK082636 
Product Classification Coil, magnetic resonance, specialty - Product Code MOS
ProductTxRx 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.
Code Information QED part numbers: Q7000057/QED000057/QSV000057 Siemens part numbers: 10606829 / 10606614  Serial #s: 1002-1012, 1016-1020, and 1022.
FEI Number 3007350713
Recalling Firm/
Manufacturer		 Quality Electrodynamics LLC
700 Beta Dr Ste 100
Mayfield Village OH 44143-2378
For Additional Information ContactChristie L. Zydyk, MBA
440-484-2228
Manufacturer 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.
FDA Determined
Cause 2		Error in labeling
ActionSince 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.
Quantity in Commerce17 units
DistributionWorldwide distribution: USA (nationwide): Tennessee only and country of: Germany
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MOS
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