Health Products

Hard Disk Drives in Azurion and Allura Systems

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Hard Disk Drives in Azurion and Allura Systems
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Allura Xper FD20 OR Table (Product Of Alluraclarity Family)Not applicable.722035
Allura Xper FD20/15Not applicable.722058
Allura Xper FD20 (Product Of Alluraclarity Family)Not applicable.722028
Allura Xper FD20/10 (Product Of Alluraclarity Family)Not applicable.722029
Azurion 7 M12Not applicable.722 223
Azurion 7 M12Not applicable.722 078
Azurion 7 B12Not applicable.722 067
Allura Xper FD20/20 (Product Of Alluraclarity Family)Not applicable.722038
Allura Xper FD10 (Product Of Alluraclarity Family)Not applicable.722026
Azurion 7 B20Not applicable.722 068
Allura Xper FD10Not applicable.001443
Allura Xper FD10/10 (Product Of Alluraclarity Family)Not applicable.722027
Azurion 7 M20Not applicable.722 224
Azurion 7 M20Not applicable.722 079

Issue

Philips has identified that Hard Disk Drives (HDDs) used in the PCS of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.

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