FDA-Device2012-09-12Class II
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.
Quality Electrodynamics LLC
Hazard
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.
Sold states
Worldwide distribution: USA (nationwide): Tennessee only and country of: Germany
Affected count
17 units
Manufactured in
700 Beta Dr Ste 100, N/A, Mayfield Village, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2314-2012Don't want to check this manually?
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