Health product recall

Allura Xper Systems

Last updated

Summary

Product
Allura Xper Systems
Issue
Medical devices - Device compatibility
What to do

Contact the manufacturer if you require additional information. 

Affected products

Affected products

Lot or serial number

Model or catalog number

Allura Xper FD20/20 (Product Of Alluraclarity Family)

Not applicable.

722038

Allura Xper FD20 OR Table (Product Of Alluraclarity Family)

Not applicable.

722058

Allura Xper FD10

608

001443

Allura Xper FD10/10 (Product Of Alluraclarity Family)

Not applicable.

722027

Allura Xper FD20/10 (Product Of Alluraclarity Family)

Not applicable.

722029

Allura Xper FD10 (Product Of Alluraclarity Family)

1115

722026

Allura Xper FD20 (Product Of Alluraclarity Family)

1094

722028

Allura Xper FD20 (Product Of Alluraclarity Family)

1681

722028

Allura Xper FD20 (Product Of Alluraclarity Family)

2282

722028

Issue

Philips has identified that a component (air baffle) may be potentially missing in some Nehalem FlexVision-2 PCs that are part of the Allura XPER series.

The air baffle directs part of the airflow inside the PC. When it is not installed, the temperature of the frame grabber card of the FlexVision PC-2 may be outside the specified temperature range, which may lead to an increased probability of failure of the frame grabber card. If this occurs, no image will be shown in the FlexVision monitor of the exam room. 

Recall start date: August 1, 2025

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
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-77920

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