FDAJuly 6, 2015device

SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Wrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the QBC. The combined use of the Sense coil, high SAR level scanning and placement of the cables contrary to instructions for use can lead to patient burns.

What to do

FDA enforcement status: Terminated

Brands named

philips electronics north americaphilipsphilips electronics

UPCs

459800359051

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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