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 B12; Lot or serial number: 128; Model or catalogue number: 722 067
Affected products: Azurion 7 B12; Lot or serial number: 151; Model or catalogue number: 722 067
Affected products: Azurion 7 M12; Lot or serial number: 119; Model or catalogue number: 722 223
Affected products: Azurion 7 M12; Lot or serial number: 205; Model or catalogue number: 722 078
Affected products: Azurion 7 M12; Lot or serial number: 444; Model or catalogue number: 722 078
Affected products: Azurion 7 M12; Lot or serial number: 218; Model or catalogue number: 722 078
Affected products: Azurion 7 M12; Lot or serial number: 206; Model or catalogue number: 722 078
Affected products: Azurion 7 M12; Lot or serial number: 204; Model or catalogue number: 722 078
Affected products: Azurion 7 M20; Lot or serial number: 3459; Model or catalogue number: 722 224
Affected products: Azurion 7 M20; Lot or serial number: 874; Model or catalogue number: 722 224
Affected products: Azurion 7 M20; Lot or serial number: 2667; Model or catalogue number: 722 224
Affected products: Azurion 7 M20; Lot or serial number: 495; Model or catalogue number: 722 224
Affected products: Azurion 7 M20; Lot or serial number: 1156; Model or catalogue number: 722 224
Affected products: Azurion 7 M20; Lot or serial number: 3596; Model or catalogue number: 722 224
Affected products: Azurion 7 M20; Lot or serial number: 875; Model or catalogue number: 722 224
Affected products: Azurion 7 M20; Lot or serial number: 284; Model or catalogue number: 722 079
Affected products: Azurion 7 M20; Lot or serial number: 333; Model or catalogue number: 722 079
Affected products: Azurion 7 M20; Lot or serial number: 1374; Model or catalogue number: 722 079
Affected products: Azurion 7 M20; Lot or serial number: 783; Model or catalogue number: 722 079
Affected products: Azurion 7 M20; Lot or serial number: 750; Model or catalogue number: 722 079
Affected products: Azurion 7 M20; Lot or serial number: 679; Model or catalogue number: 722 079
Affected products: Azurion 7 M20; Lot or serial number: 352; Model or catalogue number: 722 079
The hazard
Philips Azurion systems use solid-state drives (SSDs) in various PCs to store the operating system and image data and to support system functionality. Philips has identified that, during certain repair or service actions, SSDs that are not specified in the medical device file may have been installed. These SSDs may have different performance characteristics, which may include reduced reliability over time.
When an SSD does not perform as intended, the symptoms depend on the PC in which the SSD is installed and the function being used. this may result in loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.
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)