Public recall detail

Philips MR System Breast Coil

2024-11-15

medium
Recall Safety notice
Quick summary

Quick summary: Philips MR System Breast Coil . Date: 2024-11-15.

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 MR System Breast Coil . Date: 2024-11-15.

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 MR System Breast Coil
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76517

Affected products

ProductDs Breast
LotNot applicable.
Model4598-017-29881 4598-017-29902
Serial numberNot applicable.
DescriptionDs Breast
ProductLBS Breast Array Coil
LotNot applicable.
Model4535-302-8072X 4535-302-8089X 4598-012-9071X 4535-302-2888X 4535-302-8088X
Serial numberNot applicable.
DescriptionLBS Breast Array Coil

Issue

Philips has identified an issue with patient set up while using the MR system breast coil where, if the cross-section of the prone patient, breast coil, and patient table exceeds the internal diameter of the magnet bore, the patient may be compressed between the breast coil and top of the magnet bore potentially resulting in harm to the patient. Recall start date: November 7, 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 II
Alert / recall typeHealth product recall
Identification numberRA-76517
Background{}
CompaniesPhilips Medical Systems Nederland B.V. Veenpluis 6, Best, Netherlands, 5684 PC
AudiencesHealthcare
Source updated2024-11-15

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

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