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To date, Health Canada has authorized licence amendments for all DreamStation CPAP and Bi-level Therapy devices (other than DreamStation Go devices). Philips has yet to submit packages to Health Canada for A-Series, DreamStation Go, OmniLab, and Trilogy devices.
- Philips BiPAP and Humidifiers - Canada.ca
Full validation requires biological evaluation after...
- Continuous Positive Airway Pressure (CPAP), Bi-Level Positive ... - Canada
Health product recall. Continuous Positive Airway Pressure...
- Philips BiPAP and Humidifiers - Canada.ca
30 Ιουλ 2021 · Philips Respironics (Philips) has recalled several models of its Continuous Positive Airway Pressure (CPAP) machines, BiLevel Positive Airway Pressure (BiLevel PAP) machines and mechanical ventilators in Canada and internationally.
10 Ιουλ 2023 · 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.
27 Σεπ 2023 · In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only).
Health product recall. Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiPAP), and Mechanical Ventilators (2021-06-14) Starting date: June 14, 2021. Posting date: June 23, 2021. Type of communication: Medical Device Recall. Subcategory: Medical Device. Hazard classification: Type I. Source of recall: Health Canada.
16 Μαΐ 2023 · Building on past reports, the risk assessments have now been completed for the CPAP/BiPAP sleep therapy devices, including the first-generation DreamStation, System One and DreamStation GO devices. These devices represent approximately 95% of the registered devices globally.
Registration for affected CPAP and BiPAP devices in Canada ends at 11:59 p.m. EST, December 31, 2024. To receive a replacement device, please be sure to register your device prior to the end of the year.
