CanadaPhilips Allura Xper FD series angiography systems (Allura R8.2 with AD7x patient table type), including models/catalogue numbers 722028 (Allura Xper FD20), 722038 (FD20/20), 722058 (FD20/15) and 722026 (FD10), are affected. A firmware issue in the Advanced Motion Controller can disable manual and motorized geometry movements after a system start or restart without displaying a message, while X‑ray imaging remains available. The issue can be resolved by performing a cold restart or restarting the geometry; contact the manufacturer for 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 FD20 (Product Of Alluraclarity Family); Lot or serial number: Not applicable.; Model or catalogue number: 722028
Affected products: Allura Xper FD20/20 (Product Of Alluraclarity Family); Lot or serial number: Not applicable.; Model or catalogue number: 722038
Affected products: Allura Xper FD20/15; Lot or serial number: Not applicable.; Model or catalogue number: 722058
Affected products: Allura Xper FD10 (Product Of Alluraclarity Family); Lot or serial number: Not applicable.; Model or catalogue number: 722026
The hazard
Philips has identified a potential safety issue affecting Allura R8.2 systems equipped with a AD7x patient table type potentially leading to loss of geometry movements. In some cases, following a system (re)start, manual and motorized geometry movements may be disabled due to a firmware issue in the Advanced Motion Controller (AMC) single-axis motion control unit used in the AD7x tables of Allura R8.2 systems. When the issue occurs, no message is displayed to the user. In this situation, X-ray imaging is available. The issue can be resolved by performing a cold restart of the system or by restarting the geometry.
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)