Philips BiPAP and Humidifiers
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| BiPAP A40 Pro, CA | All lots. | CAX3100S12 |
| BiPAP A40, Canada, Core Package | All lots. | 1111174 |
| BiPAP A30 System - Ventilator & System One Aseries Heated Humidifier | All lots. | 1111148 |
| BiPAP A40 EFL | All lots. | INX3T |
| System One Heated Humidifier | All lots. | IN6T INX3T IN6TFLG IN6H INX3H IN6HFLG |
| BiPAP A40 Pro, CA W/ Heated Tube Humidifier, CA | All Lots. | CAX3100T12 |
| System One A-Series Heated Humidifier | All Lots. | 1111552 1077107 1111555 |
Issue
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.
Recall Start Date: June 30, 2023
Additional information
Details
Respironics Inc. Also Trading As Philips Rs North America LLC
1001 Murry Ridge Lane, Murrysville, Pennsylvania, United States, 15668
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