Health product recall

Allura Xper FD10

Last updated

Summary

Product
Allura Xper FD10
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Allura Xper FD10 Not 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.

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 II
Recall date
Identification number
RA-82292

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