Recall Z-2314-2012— Quality Electrodynamics LLC

Name: FDA recall Z-2314-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-27

Class II · Terminated

Class II FDA medical device recall by Quality Electrodynamics LLC, initiated 2012-07-27, terminated 2013-02-19. It names one FDA 510(k) clearance: K082636. Product: 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: 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..

Recalling firm: Quality Electrodynamics LLC
Classification: Class II
Status: Terminated
Initiated: 2012-07-27
Terminated: 2013-02-19
Firm location: Mayfield Village, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K082636 — TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3TQuality Electrodynamics·cleared 2008-09-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.