Z-2314-2012Class II

TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of...

Name: Z-2314-2012 TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of...
Creator: Quality Electrodynamics LLC
Published: 2012-07-27
License: https://open.fda.gov/license/

Quality Electrodynamics / initiated 2012-07-27 / Terminated / root cause: labeling and UDI

FDA source

Quality Electrodynamics LLC began a recall of 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... on 2012-07-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2314-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-27
Posted: 2012-09-06
Terminated: 2013-02-19
Recalling firm: Quality Electrodynamics
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.
Product code: MOS Coil, Magnetic Resonance, Specialty
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Since 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 commerce: 17 units
Distribution: Worldwide distribution: USA (nationwide): Tennessee only and country of: Germany
Product codes and lots: QED part numbers: Q7000057/QED000057/QSV000057 Siemens part numbers: 10606829 / 10606614 Serial #s: 1002-1012, 1016-1020, and 1022.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2314-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2314-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-12	2012-09-06

Product code MOS

K082636Class IITxrx 15Ch Knee Coil (1.5T and 3T), Txrx Cp Extremity Coil 3TQuality Electrodynamics / cleared 2008-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)