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Terminated

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

FDA Recall Z-1024-2016 · Posted 2016-02-26

Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeLNH
Date Initiated2015-07-06
Date Terminated2017-08-29
Product Quantity5672

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.

Firm Action

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

Distribution Pattern

US: Nationwide OUS: Canada, Afghanistan Albania Algeria Andorra Argentina Australia Austria Azerbaijan Bahamas Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Botswana Brazil Burkina Faso Chile China Colombia Columbia Congo, Democratic Costa Rica Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt Estonia Ethiopia Finland France Georgia Germany Ghana Greece Guadeloupe Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Israel Italy Japan Jersey Jordan Kazakhstan Kenya Korea, Republic of Kuwait Kyrgyzstan Latvia Lebanon Libya Lithuania Luxembourg Malaysia Malta Martinique Mauritius Mexico Monaco Mongolia Morocco Mozambique Nepal Netherlands New Caledonia New Zealand Norway Oman Pakistan Palestinian territory, occupied Panama Papua New Guinea Peru Philippines Poland Portugal Puerto Rico Romania Russian Federation Rwanda Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sudan Sweden Switzerland Syrian Arab Republic Taiwan Tanzania Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Venezuela Viet Nam Yemen Zimbabwe

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030520INTERA FAMILYPhilips Medical Systems North America Co. · 2003-03-06K013344INTERA I/TPhilips Medical Systems North America Co. · 2001-12-11K001796GYROSCAN INTERA (R7.5)Philips Medical Systems North America, Inc. · 2000-09-06K945945GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NTPhilips Medical Systems North America, Inc. · 1995-12-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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