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

FDA device recall Z-1024-2016 · posted 2016-02-26 · Terminated

Recall details

Recalling firm

Philips Electronics North America Corporation

Reason for recall

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.

Action taken

On 6/18/2015, the Field Safety Notice / Medical Device Correction Notice was sent to customers via certified mailing. The letter explains the issue and provides user instructions. A sleeve is being developed that will be applied to the cable on the Sense Body Coil 1.5T and provide consistent spacing between the cable and the patient, thereby reducing the chance of RF interaction and heating. This sleeve will be distributed as part of a Field Change Order with reference FCO781 00437 for Sense Body Coils in the installed base and will be installed by the Philips Field Service Engineers.

Root cause

Device Design

Status

Terminated

Product code

LNH

Quantity affected

5672

Distribution

US: Nationwide OUS: Canada, Afghanistan Albania Algeria Andorra Argentina Australia Austria Azerbaijan Bahamas Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Botswana Brazil Burkina Faso Ch

Date initiated

2015-07-06

Date posted

2016-02-26

Date terminated

2017-08-29

Location

Andover, MA

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