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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