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U.S. Department of Health and Human Services

Enforcement Report - Week of September 12, 2012

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Event Detail

Event ID 62949
Product Type Devices
Status Ongoing
Recalling Firm Quality Electrodynamics LLC
City Mayfield Village
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-27
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide distribution: USA (nationwide): Tennessee only and country of: Germany

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. QED part numbers: Q7000057/QED000057/QSV000057 Siemens part numbers: 10606829 / 10606614 Serial #s: 1002-1012, 1016-1020, and 1022. Class II 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. 17 units Z-2314-2012