Health product recall

Philips SENSE XL Torso (1.5T and 3.0T) coils

Last updated

Summary

Product
Philips SENSE XL Torso (1.5T and 3.0T) coils
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Achieva 3.0T MRI System - Sense Torso Coil Not applicable. 4535 673 94942 4535-673-9494X
Intera 1.5T MRI System - Sense XL Torso Coil Not applicable. 453567141882 453567141883
Achieva 1.5T MRI System - Sense Torso Coil Not applicable. 453567141882 453567141883 4535 675 02881
Achieva XR System - Sense Coil Not applicable. 453567141882 453567141883 453567394942

Issue

Philips has been made aware through customer complaints of a potential safety issue with specific SENSE XL Torso (1.5T and 3.0T) coils that could pose a risk for patients. Philips has identified an issue in the SENSE XL Torso (1.5T and 3.0T) coils which may result in localized heating during the scan, resulting in potential harm to patients. If the patient is exposed to localized heating there is a potential for a heating sensation and/or 1st, 2nd, or 3rd degree burns around the area covered by the coil.

Recall start date: June 6, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Philips Medical Systems Nederland B.V.

Veenpluis 6, Best, Netherlands, 5684 PC

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-75658

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