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.
If you have questions or would like to learn more about what this means for you, please feel free to contact Dr. Shahin (Shawn) at Viva Dental Wellness, he will be more than happy to assist you.
Looking for a safe, reliable and convenient alternative?
According to the American Academy of Dental Sleep Medicine, oral appliance therapy (OAT) is a clinically proven treatment for millions of patients with obstructive sleep apnea (OSA).
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If you have questions or would like to learn more about what this means for you, please feel free to contact Dr. Shahin (Shawn) at Viva Dental Wellness, he will be more than happy to assist you.
Learn More About the Philips Respironics Recall
- 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.
- 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.
- 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.
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 headache, 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.
| 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 |
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.