CanadaAllura Xper FD10 angiography systems (model/catalogue number 001443) are affected; identify by the product name Allura Xper FD10 from Philips Medical Systems Nederland B.V. Philips found that during certain repairs or service actions hard disk drives with different performance characteristics than specified may have been installed, which can reduce reliability over time and may result in loss of imaging functionality and, in Allura systems, loss of motorized movement or loss of data. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Philips Medical Systems Nederland B.V., Veenpluis 6, Best, Netherlands, 5684 PC.
How to identify it
Affected products: Allura Xper FD10; Lot or serial number: Not applicable.; Model or catalogue number: 001443
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)