CanadaAzurion Systems (models Azurion 7 M12, 7 B12, 5 M20, 7 M20 and 7 B20; catalogue numbers 722233, 722223, 722078, 722067, 722235, 722232, 722224, 722079, 722234, 722068, 722226, 722236) are affected. Philips identified two software-related issues in Azurion R2.x.10, R3.0, R3.1 and R4.0 that may cause image quality degradation and, for systems with an AD7X table, loss of geometry movements, which may result in delay of therapy, procedural complications and/or inappropriate treatment. 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: Azurion 7 M12; Lot or serial number: Not applicable.; Model or catalogue number: 722233
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: 722078
Affected products: Azurion 7 B12; Lot or serial number: Not applicable.; Model or catalogue number: 722067
Affected products: Azurion 7 B12; Lot or serial number: Not applicable.; Model or catalogue number: 722235
Affected products: Azurion 5 M20; Lot or serial number: Not applicable.; Model or catalogue number: 722232
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: 722079
Affected products: Azurion 7 M20; Lot or serial number: Not applicable.; Model or catalogue number: 722234
Affected products: Azurion 7 B20; Lot or serial number: Not applicable.; Model or catalogue number: 722068
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: 722236
The hazard
Philips has identified two software-related issues affecting Azurion R2.x.10, R3.0, R3.1 and R4.0 systems that may result in delay of therapy, procedural complications and/or inappropriate treatment.
Issue 1: Image quality degradation
Issue 2: Loss of geometry movements - Applicable to systems with an AD7X table only
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)