Health product recall

Philips MR System Breast Coil

Last updated

Summary

Product
Philips MR System Breast Coil
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 catalogue number
Ds Breast Not applicable. 4598-017-29881 4598-017-29902
LBS Breast Array Coil Not applicable. 4535-302-8072X 4535-302-8089X 4598-012-9071X 4535-302-2888X 4535-302-8088X

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

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 II
Identification number
RA-76517

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