Recall Monitor
Health Products

Allura Xper FD10

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Allura Xper FD10
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 FD10Not applicable.001443

Issue

Philips has identified through customer complaints that, during certain repair or service actions, Hard Disk Drives (HDD) with different performance characteristics than those specified by the legal manufacturer may have been installed. These HDDs may exhibit reduced reliability over time, which may result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement or loss of data. In addition, Philips has identified that in some Allura systems, HDDs compliant with specifications but of different types have been used within a single system, whereas specifications require identical HDD types. While these systems are not in line with the released configuration, Philips confirms that this does not result in any noticeable performance impact or safety risk.

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