Advisory - Update on Philips Respironics recall of several models of CPAP and BiLevel PAP machines and mechanical ventilators

OTTAWA, ON, July 5, 2024 /CNW/ -

Summary

• Products: Philips Respironics Continuous Positive Airway Pressure (CPAP) machines, BiLevel Positive Airway Pressure (BiLevel PAP) machines and mechanical ventilators
• Issue: Medical Devices – Quality issue
• What to do:
  • Talk to your physician or medical device provider before stopping or changing how you use your product, as the benefits of using these devices may outweigh the risks for many users.
  • Register your device on the Philips recall website or call 1-877-907-7508. Philips has established a registration process where you can look up your device serial number and begin a claim if your unit is affected.
  • If you are a patient inquiring about the status of the remediation of your device, you can contact Philips at [email protected]
  • Clean your device only according to the manufacturer's Instructions for Use, as the use of non-validated cleaning methods could contribute to potential issues.

UPDATE (2024-07-05): Update on Philips Respironics recall of several models of CPAP and BiLevel PAP machines and mechanical ventilators

Since 2021, Philips Respironics (Philips) has established a registration portal, as a part of their repair and replacement program, for affected CPAP and BiLevel PAP machines and mechanical ventilators in Canada. Philips Respironics plans to close its registration portal at the end of December 2024, with the goal of completing its repair and replacement program in Canada by the end of June 2025. As a result, the company is asking all customers who have not yet registered their devices to do so as soon as possible.

As noted in previous communications, consumers with an affected device should register their device at the Philips recall website or by calling 1-877-907-7508. If you are not sure whether your product is affected, during the registration process, you can look up your device serial number and begin a claim if your unit is affected. The recall only affects models manufactured before April 26, 2021. 

Once consumers have completed the registration process, they need to contact their health care provider and/or durable medical equipment provider to initiate the remediation process, who will coordinate device repairs and replacements, and help patients secure and set up medical equipment for home use. To inquire about the status of the remediation, you can contact Philips at [email protected].

If you currently own a recalled device and do not have an account with a health care provider or durable medical equipment provider and do not have a completed device registration, Philips advises you to:

• Conduct an internet search for "Canadian CPAP providers near me," and
• Contact a provider listed in the results of the search to arrange for the replacement of the device.

Alternatively, if you have completed your device registration, you can connect with a durable medical equipment provider through Philips.

Health Canada continues to closely monitor the company's progress in resolving the safety issue and implementing a repair and replacement program for affected devices in Canada.

UPDATE (2022-07-27): Update on Philips Respironics recall of several models of CPAP and BiLevel PAP machines and mechanical ventilators 

Health Canada is providing an update on the progress of Philips Respironics' (Philips) recall of several models of CPAP and BiLevel PAP machines and mechanical ventilators in Canada. Since communicating about the recall in July 2021 (see below), Health Canada has been receiving questions from individuals who rely on these devices. The Department wants to reassure patients and their families that their health and well-being is a priority. The Department is closely monitoring the company's progress in resolving the safety issue and implementing a repair and replacement program for affected devices in Canada. Health Canada's safety recommendations have not changed from its July 2021 advisory.

Progress on remediation plan to date:

Philips has confirmed that it is repairing or replacing all devices affected by this recall, irrespective of the age of the device. Philips may replace devices with the same model, or a different Philips device that will meet the needs of the patient. Philips has advised Health Canada that it expects to complete its repair and replacement program in Canada by the end of 2023.

As part of the company's remediation plan, Philips will submit licence amendments for any proposed device design or material changes to address the foam degradation and off-gassing issues. The submissions must provide evidence that the safety concern has been addressed and that the changes are safe. While Health Canada cannot compel a company to submit a licence amendment, or to submit it within a certain timeline, the Department is prioritizing and expediting the review of each of these amendment packages when it receives them. 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.

Once a licence amendment is authorized by Health Canada, Philips has indicated that it may take up to a year for that product to be repaired or replaced.

Importance of working with Durable Medical Equipment Providers

If you are a user of a recalled device, or you are unsure, please see the section below on What you should do. It is important that those affected by the recall register their device with Philips if they have not done so already. Users can register on the Philips recall website or by calling 1-877-907-7508. Philips has informed Health Canada that it is working through its Canadian network of medical device providers, known as Durable Medical Equipment Providers (DMEs), to coordinate device repairs and replacements. Users who do not currently have a DME can connect with one through Philips if they have registered their device with the company.

Device supply in Canada

This recall is global and affects millions of devices. The volume of recalled devices has put a strain on the worldwide supply of Philips devices and of alternatives. To help increase the availability of alternative options in Canada, Health Canada has fast-tracked its review of submissions from companies other than Philips to add devices to the List of medical devices for exceptional importation and sale. This list enables Health Canada to respond to device shortages by allowing the exceptional, temporary importation and sale of comparable medical devices not authorized for sale in Canada, but approved by other trusted regulators. To date, the following devices have been added to the list:

• a CPAP device manufactured by Breas Medical AB, and
• the iBreeze CPAP system manufactured by Resvent Medical Technology Co., Ltd.

Health Canada is in regular communication with Philips to monitor this recall and to ensure that timely updates on replacement and repair are provided to the Department and to device users in Canada.

At Health Canada's request, the company will update its Canadian website to provide more information to Canadians affected by this recall.

Original Advisory (2021-07-30): Philips Respironics recalls several models of CPAP and BiLevel PAP machines and mechanical ventilators

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. The devices include a foam component that reduces sounds from the device. This foam may degrade (break down) into particles which may be inhaled or swallowed by users, or release volatile organic compounds (VOCs) that may be inhaled, which could lead to negative health effects.

Preliminary laboratory analysis by Philips determined that extreme operating temperatures and ozone cleaning methods may increase the breakdown of the foam. The company recommends against product use in temperatures outside of the labelled operating conditions, and the use of non-validated cleaning methods, such as ozone.

Philips has issued letters to customers, patients, and distributors with instructions for the recall. Philips indicates it will replace the foam component with a material that is not affected by this issue, or it will replace affected devices altogether.

Philips reports that they have received a relatively low number of complaints, some of which relate to black debris in the device air path, including the tubing and mask. Some users have reported headaches, upper airway irritation, cough, chest pressure, and sinus infection, but it is has not yet been determined if degraded foam particles or VOCs were the cause.

Health Canada considers the benefits of using the affected devices to outweigh the risks for many users, and recommends that users not stop or alter their prescribed therapy before having a discussion with their health care professional.

For ventilators only, Health Canada cautions the use of in-line bacterial filters to mitigate foam particles, as they will not protect against VOC emissions and airflow can be negatively affected if the filter becomes clogged with debris.

What you should do

• Register your device on the Philips recall website or call its recall hotline at 1-877-907-7508. Philips has established a registration process where you can look up your device serial number and begin a claim if your unit is affected.
• If you are a patient inquiring about the status of remediation of your device, you can contact Philips at [email protected]
• If you have an affected product talk to your physician, or medical device provider first before stopping or changing how you use your product, as the benefits of using these devices may outweigh the risks for many users.
• Be sure to clean your device only according to the manufacturer's Instructions for Use, as the use of non-validated cleaning methods (e.g. ozone) could contribute to potential foam degradation.
• Do not attempt to remove or replace the foam yourself.
• Report any health product-related side effects or complaints to Health Canada.

What Health Canada is doing?

Health Canada is monitoring the recall and the availability of devices in Canada. The Department continues to work with the manufacturer to further assess potential health risks, any future design or material changes that may be proposed, and the appropriateness of the company's corrective actions.

The Department is also working with Philips to identify strategies to address any device shortages. If additional products or safety concerns are identified, Health Canada will take appropriate action and inform Canadians.

Affected products

The recall affects several models manufactured before April 26, 2021. Device photos are available on the company's recall website. 

Product	Model or catalog number
BIPAP A30 SYSTEM-VENTILATOR	1076577 1111147
BIPAP A30 SYSTEM-VENTILATOR & SYSTEM ONE A-SERIES HEATED HUMIDIFIER	1076578 1111148
BIPAP A40, CANADA	1076579 1111173
BIPAP A40, CANADA, CORE PACKAGE	1111174
BIPAP AUTO BI-FLEX, WITH HUMIDIFIER, WITH SMARTCARD, CANADA	CA751HS CA761HBT CA761HS CA761NTS CA761TBT CA761TS
BIPAP AUTO BI-FLEX, WITH SMARTCARD, CANADA	CA751S CA761BT CA761S
BIPAP AUTOSV ADVANCED SYSTEM ONE	CA951HS CA951S CA961HS CA961NTS CA961S CA961TS CA961XHS CA961XS CA961XTS
BIPAP AUTOSV ADVANCED/ENCORE SMARTCARD	1044288
BIPAP AUTOSV ADVANCED/ENCORE SMARTCARD/HEATED HUMIDIFIER	1044289
BIPAP AUTOSV WITH SMARTCARD INT	1044114
BIPAP AUTOSV WITH SMARTCARD INT, CORE PKG	1044235
BIPAP AVAPS CORE PACKAGE, NORTH AMERICA	1029750
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM-CANADA	CA1060486 CA1161X CAX1130S12
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM-CORE PKG, CANADA	CA1061419 CA1161XTS CAX1130H12 CAX1130H12C CAX1130H12W CAX1130T12 CAX1130T12C
BIPAP AVAPS, C SERIES VENTILAROTY SUPPORT SYSTEM-CORE PKG, DOMESTIC	1061418
BIPAP AVAPS, C SERIES VENTILATORY SUPPORT SYSTEM-DOMESTIC	1060485
BIPAP PRO BI-FLEX, WITH HUMIDIFIER, WITH SMARTCARD, CANADA	CA651HS CA661HBT CA661HS CA661NTS CA661TBT CA661TS
BIPAP PRO BI-FLEX, WITH SMARTCARD, CANADA	CA651S CA661S
BIPAP ST, C SERIES VENTILATORY SUPPORT SYSTEM, CORE PKG, CANADA	CA1061423
BIPAP ST, C SERIES VENTILATORY SUPPORT SYSTEM-CANADA	CA1061421
BIPAP ST, C SERIES VENTILATORY SUPPORT SYSTEM-CORE PKG, DOMESTIC	1061422
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH SMARTCARD	1029756 CA1029756
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH SMARTCARD-CORE PACK	CA1029759
DREAMSTATION BIPAP PRO	CAX600H12 CAX600H12C CAX600H12W CAX600S12 CAX600T12 CAX600T12C
DREAMSTATION AUTO BIPAP	CAX700H12 CAX700H12C CAX700H12W CAX700S12 CAX700T12 CAX700T12C CAX700T12W
DREAMSTATION AUTO CPAP	CAX500H12 CAX500H12C CAX500H12W CAX500S12 CAX500T12 CAX500T12C CAX500T12W
DREAMSTATION BIPAP AUTO SV W/HUMID/HEATED TUBE, CA	CAX900T12 CAX900T12C
DREAMSTATION BIPAP AUTOSV, CA	CAX900S12
DREAMSTATION BIPAP AUTOSV, W/HUMIDIFIER, CA	CAX900H12
DREAMSTATION CPAP	CAX200H12 CAX200S12C CAX200T12
DREAMSTATION CPAP PRO	CAX400H12 CAX400H12C CAX400H12W CAX400S12 CAX400T12 CAX400T12C CAX400T12W
DREAMSTATION EXPERT	CAX501H12 CAX501H12C CAX501T12 CAX5O1T12C CAX5O1T12W
DREAMSTATION GO AUTO CPAP	CAG500S12
DREAMSTATION GO AUTO CPAP WITH HUMIDIFIER, CANADA	CAG500H12
DREAMSTATION GO CPAP	CAG400S12
DREAMSTATION GO CPAP WITH HUMIDIFIER, CANADA	CAG400H12
OMNILAB ADVANCED, DOMESTIC	1111122
OMNILAB ADVANCED, DOMESTIC CORE	1111123 1111124
REMSTAR AUTO WITH HUMIDIFIER, WITH SD CARD, A-FLEX, CANADA	CA551HS CA561HBT CA561HS CA561NTBT CA561NTS CA561TBT CA561TS
REMSTAR AUTO WITH SD CARD, A-FLEX, CANADA	CA551S CA561BT CA561S
REMSTAR PLUS WITH HUMIDIFIER, WITH SD CARD, C-FLEX, CANADA	CA251HS CA261HS CA261NTS CA261TS
REMSTAR PLUS WITH SD CARD, C-FLEX, CANADA	CA251S CA261S
REMSTAR PRO WITH HUMIDIFIER, WITH SD CARD, C-FLEX +, CANADA	CA451HS CA461HBT CA461HS CA461NTBT CA461NTS CA461TBT CA461TS
REMSTAR PRO WITH SD CARD, C-FLEX +, CANADA	CA451S CA461BT CA461S
REMSTAR, WITH SMARTCARD, CANADA	CA151S
REMSTAR, WITH HUMIDIFIER, WITH SMARTCARD, CANADA	CA151HS
TRILOGY 100 VENTILATOR, CANADA	CA1054096 CA1054096B U1054260
TRILOGY 100 VENTILATOR-INTERNATIONAL	1054096 U1054096
TRILOGY 200, CANADA	CA1032800 CA1032800B

Related links

• Philips Respironics recall website

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SOURCE Health Canada (HC)

Media Enquiries: Health Canada, [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709