Reported Sep 12, 2012 · Terminated
TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee…
Quality Electrodynamics LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Quality Electrodynamics LLC · 700 Beta Dr Ste 100 · Mayfield Village, OH · 44143-2378
Is this the product you have?
- 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.
- Lot codes and dates
- QED part numbersQ7000057/QED000057/QSV000057
- Siemens part numbers
10606829 / 10606614 Serial #s: 1002-10121016-1020and 1022
- Amount recalled
- 17 units
Where it was sold
- Nationwide
- TN
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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