The Recall Desk
SevereFDA (Devices)·Z-1024-2016·Announced 2016-03-09

Philips SENSE Body Coil 1.5T Recalled for Potential Patient Burns

Philips is recalling 5,672 SENSE Body Coil 1.5T units because improper cable placement can cause patient burns during MRI scans.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of patient burns, which aligns with the rubric criteria for Severe severity (FDA Class II with significant injury reports or potential for serious harm).

Plain-English summary

Philips Electronics North America Corporation is recalling 5,672 SENSE Body Coil 1.5T units used in ACS NT, Intera 1.5T, and Achieva 1.5T MR systems. The recall is due to a risk of patient burns caused by unintended resonances or elevated cable temperatures when the coil cables are positioned contrary to instructions.

The hazard occurs when the Sense coil is used with high SAR level scanning and the cables are placed incorrectly, leading to coupling with the QBC. This combination can create unintended resonances via the patient or cause the coil cables to overheat.

The affected units were distributed nationwide in the United States and in numerous countries internationally. Healthcare facilities using these specific MRI systems should stop using the affected coils and contact Philips for further instructions on the recall.

The recalled product

Product
SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
Affected units
5,672

Distribution

Distributed nationwide across the United States.

Same manufacturer · Philips Electronics North America Corporation

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