Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods.Īdditionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps.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.and Canada) / field safety notice (International Markets) advises patients and customers to take the following actions: Additionally, the notification provides details of our robust and comprehensive repair and replacement program, to correct this issue as efficiently and thoroughly as possible. and Canada) / field safety notice (International Markets) informs customers and users of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken. and Canada) / field safety notice (International Markets) for specific affected devices. As a result of extensive ongoing review following this announcement, on June 14, 2021, the company issued a recall notification (U.S. The company also indicated that analysis of potential health risks was ongoing, and that further information would be provided when available.
#PHILIPS RESPIRONICS RECALL UPDATE#
Read the full recall notice from Philips Respironics Ventilators here or the Philips Respironics CPAP machines here.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), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see FDA safety communication on use of Ozone cleaners), and off-gassing may occur during operation. Philips Respironics is voluntarily recalling the below devices due to two (2) issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and NonContinuous Ventilators: 1) PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals. We are working alongside the manufacturer, Philips Respironics, to access updates and develop plans for PHS and COHSC families.
PHS was made aware of a respiratory device recall on Monday, June 14. PHS continues to encourage patients to register their patient-owned CPAP devices to begin the replacement/repair process through Philips. This is an important milestone that continues to drive the importance of device registration. Philips Respironics has received FDA approval for the sound abatement foam in the CPAP devices.
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