CanadaPhilips Allura Xper and Azurion X-ray systems identified by the model/catalogue numbers listed in the notice (for example Allura Xper FD10, model 722026, and Azurion 7 M20, model 722224) are affected. The wired foot switch may not initiate X‑ray or may function intermittently due to cable or connector damage, internal microswitch failure, or foot switch connector/strain relief issues, which could delay or abort a procedure. 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 (Product Of AlluraClarity Family); Lot or serial number: Not applicable.; Model or catalogue number: 722026
Affected products: Allura Xper FD10/10 (Product Of AlluraClarity Family); Lot or serial number: Not applicable.; Model or catalogue number: 722027
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 M20; Lot or serial number: Not applicable.; Model or catalogue number: 722234
Affected products: Allura Xper FD20/15; Lot or serial number: Not applicable.; Model or catalogue number: 722058
Affected products: Allura Xper FD10; Lot or serial number: Not applicable.; Model or catalogue number: 001443
Affected products: Allura Xper FD20/10 (Product Of AlluraClarity Family); Lot or serial number: Not applicable.; Model or catalogue number: 722029
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: 722 078
Affected products: Azurion 3 M12; Lot or serial number: Not applicable.; Model or catalogue number: 722 063
Affected products: Azurion 3 M12; Lot or serial number: Not applicable.; Model or catalogue number: 722 221
Affected products: Azurion 3 M12; Lot or serial number: Not applicable.; Model or catalogue number: 722229
Affected products: Azurion 5 M12; Lot or serial number: Not applicable.; Model or catalogue number: 722 227
Affected products: Azurion 5 M12; Lot or serial number: Not applicable.; Model or catalogue number: 722231
Affected products: Azurion 5 M20; Lot or serial number: Not applicable.; Model or catalogue number: 722 228
Affected products: Azurion 5 M20; Lot or serial number: Not applicable.; Model or catalogue number: 722232
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: 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
Affected products: Azurion 7 B20; Lot or serial number: Not applicable.; Model or catalogue number: 722 068
Affected products: Azurion 3 M15; Lot or serial number: Not applicable.; Model or catalogue number: 722230
Affected products: Azurion 3 M15; Lot or serial number: Not applicable.; Model or catalogue number: 722 064
Affected products: Azurion 3 M15; Lot or serial number: Not applicable.; Model or catalogue number: 722 222
Affected products: Azurion 7 B12; Lot or serial number: Not applicable.; Model or catalogue number: 722 067
Affected products: Azurion 7 B12; Lot or serial number: Not applicable.; Model or catalogue number: 722235
Affected products: Azurion 7 B12; Lot or serial number: Not applicable.; Model or catalogue number: 722 225
Affected products: Allura Xper FD20 Or Table (Product Of AlluraClarity Family); Lot or serial number: Not applicable.; Model or catalogue number: 722035
The hazard
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch due to:
cable or connector damage (internal and/or external)
internal microswitch failure (each foot switch pedal activates two independent microswitches that - when both activated - release X-ray)
foot switch connector issues resulting from missing or incorrectly applied strain relief
No or intermittent X-ray could potentially result in a delay or abort of procedure.
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)