Health product recall

Philips Achieva, Intera and Ingenia Systems

Last updated

Summary

Product
Philips Achieva, Intera and Ingenia Systems
Issue
Medical devices - Performance issue
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 XR System-Main Unit

Not applicable.

ACHIEVA XR

Achieva 3.0T MRI System-Main Unit

Not applicable.

ACHIEVA 3.0T

Intera 1.5T MRI System-Main Unit

Not applicable.

INTERA 1.5T

Achieva 1.5T MRI System-Main Unit

Not applicable.

ACHIEVA 1.5T

Ingenia 3.0T

Not applicable.

3.0T

Issue

The quadrature body coil (QBC) seal adhesive may fail creating sharp edges that may come in contact with patients. The QBC seal may become loose as the patient table travels in a horizontal motion in and out of the system bore. The QBC seal (figure 1) is a rubber seal that is glued between the cone cover and QBC cover and functions to prevent sharp edges of the QBC cover from contacting patients during an examination.

Recall start date: January 9, 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-74922

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