TxRx Knee 15 Coil 3T — Class II medical device recall Z-2314-2012
Terminated recall by Quality Electrodynamics LLC, reported 2012-09-12, distributed nationwide. On July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not functional because th
| Recall number | Z-2314-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quality Electrodynamics LLC, Mayfield Village, OH, United States |
| Recall initiated | 2012-07-27 |
| Classified | 2012-09-06 |
| Reported by FDA | 2012-09-12 |
| Terminated | 2013-02-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE |
| Quantity | 17 units |
| Serial numbers | 1002-1012, 1016-1020, 1022 |
| Model numbers | 10606614, 10606829, Q7000057/QED000057/QSV000057 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2314-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.