We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. Philips is recommending that customers and patients do not use ozone-related cleaning products.Īdditionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are recommended to be replaced after five years of use.
For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks.
The notification advises patients and customers to take the following actions: High heat and high humidity environments may also contribute to foam degradation in certain regions.Īt the time of the June 2021 recall / field safety notice, Philips had received a limited number of reports of possible patient impact due to foam degradation, and no reports regarding patient impact related to chemical emissions. Philips continues to monitor complaints received following the recall / field safety notice via our Quality Management System, in accordance with the medical devices regulations and laws in the markets that we serve. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. The notification informs customers and users of potential impacts on patient health and clinical use related to this issue. only) / field safety notice (Outside of U.S.) for specific affected devices. The company also indicated that analysis of potential health risks was ongoing, and that further information would be provided when available.Īs a result of extensive ongoing analysis following this announcement, on June 14, 2021, the company issued a recall notification (U.S.
#Video sound cleaning lab serial number update#
On April 26, 2021, Philips provided an important update regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio.Īt that time, out of an abundance of caution and based on available information, Philips advised of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.
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