Health Products

Allura Xper Systems

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Allura Xper Systems
Issue: Medical devices - Device compatibility
What to do: Contact the manufacturer if you require additional information.
Audience: General public, Healthcare, Industry
Recall class: Type II
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Products

Affected productsLot or serial numberModel 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 FD10608001443
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)1115722026
Allura Xper FD20 (Product Of Alluraclarity Family)1094722028
Allura Xper FD20 (Product Of Alluraclarity Family)1681722028
Allura Xper FD20 (Product Of Alluraclarity Family)2282722028

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

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