Public recall detail

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

2024-06-13

medium
Recall Safety notice
Quick summary

Quick summary: Philips SENSE XL Torso (1.5T and 3.0T) coils. Date: 2024-06-13.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Philips SENSE XL Torso (1.5T and 3.0T) coils. Date: 2024-06-13.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ProductPhilips SENSE XL Torso (1.5T and 3.0T) coils
IssueMedical devices - Performance
Recall classType I
IdentificationRA-75658

Affected products

ProductAchieva 3.0T MRI System - Sense Torso Coil
LotNot applicable.
Model4535 673 94942 4535-673-9494X
Serial numberNot applicable.
DescriptionAchieva 3.0T MRI System - Sense Torso Coil
ProductIntera 1.5T MRI System - Sense XL Torso Coil
LotNot applicable.
Model453567141882 453567141883
Serial numberNot applicable.
DescriptionIntera 1.5T MRI System - Sense XL Torso Coil
ProductAchieva 1.5T MRI System - Sense Torso Coil
LotNot applicable.
Model453567141882 453567141883 4535 675 02881
Serial numberNot applicable.
DescriptionAchieva 1.5T MRI System - Sense Torso Coil
ProductAchieva XR System - Sense Coil
LotNot applicable.
Model453567141882 453567141883 453567394942
Serial numberNot applicable.
DescriptionAchieva XR System - Sense Coil

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesPhilips Medical Systems Nederland B.V. Veenpluis 6, Best, Netherlands, 5684 PC
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-75658
Background{}
CompaniesPhilips Medical Systems Nederland B.V. Veenpluis 6, Best, Netherlands, 5684 PC
AudiencesHealthcare
Source updated2024-06-13

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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