FDAClass IISeptember 12, 2012

TxRx Knee 15 Coil 3T. For use in conjunction with recall

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…

Why was TxRx Knee 15 Coil 3T. For use in conjunction with 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

QED part numbers: Q7000057/QED000057/QSV000057 Siemens part numbers: 10606829 / 10606614 Serial #s: 1002-1012, 1016-1020, and 1022.

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…
Recalling firm
Quality Electrodynamics LLC
Quantity
17 units
Distribution
Worldwide distribution: USA (nationwide): Tennessee only and country of: Germany
Recall date
September 12, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls