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Medical Device Field Safety Notice (Outside of U.S.)

Philips Respironics

*The recall notification is for U.S. only and works as a field safety notice in the rest of the world. In Hong Kong, Philips has proactively issued a ‘Medical Device field safety notice’ to notify affected customers.

Information for Physicians and other medical care providers​

Philips Respironics announced a voluntary recall notification (U.S. only) / field safety notice (Outside of U.S.) for Continuous and Non-Continuous Ventilators (certain CPAP, BiPAP and Ventilator Devices) due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices: 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. 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 initial operation and may possibly continue throughout the device’s useful life.

 

For more information on this Field Safety Notice*, including a list of affected devices, please visit Main Page Questions and Answers.

 

Philips is working tirelessly to remedy this issue by replacing the affected devices. A recall notification (U.S. only) / field safety notice (Outside of U.S.) with immediate actions to be taken has been sent to distributors and institutions that are a direct customer of Philips for their own use as well as for engagement with patients. With this, your patients are likely to contact you for guidance and we are committed to providing you with information and tools to have an
informed discussion with them and make your clinical recommendation. Please see the FAQs below and Clinical Information PDF here.


In Hong Kong market, to enquire about the Medical Device recall notification (U.S. only) / field safety notice (Outside of U.S.)* and to obtain useful information for impacted customers, users, and physicians, please call Sleep and Respiratory Care hotline at (852) 2873 1232. Customers of Philips Sleep and Respiratory Care authorized distributor in Hong Kong, Celki VitalAire, please click here for relevant information. For relevant global information, please visit www.philips.com/src-update.

For the past 40 years we have centered our business around our commitment to patient care, with solutions that are aimed at improving the lives of people with respiratory and sleep challenges. We recognize the importance of providing safe and effective therapy.

 

We are committed to holding ourselves to the highest standards of product quality and safety in an effort to do what is right for you, and the patients who trust you with their care.

 

We are committed to resolving this issue and providing transparent, ongoing communication as we navigate the next steps.

 

We are committed to providing you information and resources for your own understanding, but also to help you communicate with your patients effectively and efficiently.

For other inquiries or to speak with a support specialist, please contact Philips Sleep and Respiratory Care authorized distributor in Hong Kong, Celki VitalAire at 查詢| Celki VitalAire

 

We sincerely apologize for this disruption. We are fully committed to supporting you and your patients throughout this process.

For patients and users, The Field Safety Notice also advises: 

 

  • For patients on affected BiPAP and CPAP devices, Philips continues to recommend they discontinue use of BiPAP and CPAP devices, and consult with physicians to determine the most appropriate options for continued treatment, based on the benefits of continuing therapy and potential identified risks.
     
  • For patients on affected life-sustaining mechanical ventilator devices, do not discontinue or alter prescribed therapy without consulting with physicians, as well as instructions for modified continued use.

* 召回通知僅針對美國市場,並作為醫療設備出廠後安全通知對世界其他市場進行通知。在香港,我們已主動向受影響客戶發出「醫療設備出廠後安全通知」

**有關飛利浦睡眠和呼吸護理產品糾正計劃的全球資訊,請瀏覽www.philips.com/src-update

Disclaimer: The Chinese version of this document is a translation of the English version. In case of discrepancy in the two versions, the English version shall prevail.

免責聲明: 本文件為英文版的翻譯,可能存在差異, 請以英文版為準。

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