FDA Medical Device Recalls (openFDA)
Quality Electrodynamics LLC: 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
- Recalling firm
- Quality Electrodynamics LLC
- 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.
- Status
- Terminated
- Initiated
- 2012-07-27
- Posted
- 2012-09-06
- Terminated
- 2013-02-19
- 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.
- 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
- 17 units
- Distribution
- Worldwide distribution: USA (nationwide): Tennessee only and country of: Germany
- Lot, serial or model codes
- QED part numbers: Q7000057/QED000057/QSV000057 Siemens part numbers: 10606829 / 10606614 Serial #s: 1002-1012, 1016-1020, and 1022.
- 510(k) numbers
- ["K082636"]
- PMA numbers
- not on file
- Product code
- MOS
- Firm FEI
- 3007350713
- Firm city
- Mayfield Village
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28