Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada has posted a medical device safety alert concerning Respironics Inc. Also Trading As Philips Rs North America LLC BiPAP A30 System - Ventilator & System One Aseries Heated Humidifier, BiPAP A40 EFL, BiPAP A40 Pro, CA, BiPAP A40 Pro, CA W/ Heated Tube Humidifier, CA, BiPAP A40, Canada, Core Package, System One A-Series Heated Humidifier, System One Heated Humidifier [Model or catalog number: 1111148, INX3T, CAX3100S12, CAX3100T12, 1111174, 1111552, 1077107, 1111555, IN6T, INX3T, IN6TFLG, IN6H, INX3H, IN6HFLG; All lots] [HKMD No.: 130345, 130442, 130462, 140292].
According to Health Canada, there is currently a non-conformance regarding the disinfection method recommended in the instructions manual for devices in the field, as the Keredusy disinfection method was not adequately validated. Long term effects of this method on the device components are unknown. Full validation requires biological evaluation after cleaning cycles per ISO 10993-1 and testing on expected worse-case clinical use per ISO 18562-1. The maximum number of Keredusy cycles was also not identified within the user manuals. ISO 17664-1 does allow for the manufacturer's IFU to direct the processor to refer to the disinfecting agent manufacturer's IFU with reference to concentration, temperature, and contact time, but these parameters were not defined nor documented within the IFU. The IFU only directed the user to Philips customer service.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/philips-bipap-and-humidifiers
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 Jul 2023