Philips Electronics North America Corporation recalls SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system

Recall date

July 6, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1024-2016

FDA classification

Class II

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

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Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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