CLASS II Device recall · Reported 9 Mar 2016 · FDA Enforcement Report

Sense Body Coil 1.5T with identification recalled

Philips Electronics North America is recalling Sense Body Coil 1.5T with identification, distributed nationwide in the US. The recall was initiated on 6 Jul 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes4522 131 5575x 4522 132 1985x 4522 132 7619x 4598 000 5187x 4598 000 5189x 4598 003 59051

Quantity recalled5672

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1024-2016
FDA event ID: 73333
Recalling firm: Philips Electronics North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 6 Jul 2015
FDA classified: 26 Feb 2016
Reported: 9 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Other Medical Devices

Timeline

6 Jul 2015	Recall initiated by company
26 Feb 2016	Classified by FDA	+235 days
9 Mar 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Georgia Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

4522 131 5575x 4522 132 1985x 4522 132 7619x 4598 000 5187x 4598 000 5189x 4598 003 59051

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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