Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1024-2016 — SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system

U.S. FDA — Device Enforcement · United States · 2015-07-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1024-2016
Date of alert
2015-07-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Electronics North America Corporation
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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