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
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