CanadaWhat's being recalled
Companies: Philips Medical Systems Nederland B.V., Veenpluis 6, Best, Netherlands, 5684 PC.
How to identify it
Affected products: Azurion 7 M20; Lot or serial number: Not applicable.; Model or catalogue number: 722 224
Affected products: Azurion 7 M20; Lot or serial number: Not applicable.; Model or catalogue number: 722 079
Affected products: Azurion 7 B12; Lot or serial number: Not applicable.; Model or catalogue number: 722 067
Affected products: Azurion 7 M12; Lot or serial number: Not applicable.; Model or catalogue number: 722 223
Affected products: Azurion 7 M12; Lot or serial number: Not applicable.; Model or catalogue number: 722 078
Affected products: Azurion 7 B20; Lot or serial number: Not applicable.; Model or catalogue number: 722 226
Affected products: Azurion 7 B20; Lot or serial number: Not applicable.; Model or catalogue number: 722 068
The hazard
Philips has identified a safety issue affecting certain Azurion systems potentially leading to loss of imaging functionality.
The power distribution unit is an internal assembly of the Philips Azurion system that contains multiple power supplies. Philips has identified that, in certain Azurion systems, one or more of these power supplies can fail due to energy peaks (surge voltages) during start or restart of the system.
When a power supply failure occurs during a start or restart, the power distribution unit does not provide the required direct current power to essential system components. As a result, the system does not successfully complete the (re-)start, imaging functionality is unavailable, and the system remains unavailable for clinical use.
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)