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U.S. Department of Health and Human Services

Enforcement Report - Week of September 12, 2012

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Product Detail

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

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 Other
Distribution Pattern Worldwide distribution: USA (nationwide): Tennessee only and country of: Germany