RegWardenFDA facility compliance records
Recall

Class II — Quality Electrodynamics LLC

Recalling firmQuality Electrodynamics
Registered facilityQUALITY ELECTRODYNAMICS (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonOn 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.
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.
Quantity17 units
DistributionWorldwide distribution: USA (nationwide): Tennessee only and country of: Germany
Initiated2012-07-27
Classified2012-09-06
Terminated2013-02-19
Recall numberZ-2314-2012
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Quality Electrodynamics LLC (Z-2314-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62949/

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