Dental Clinic in Windermere Edmonton

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. Charkhandeh 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).

OAT is far less cumbersome than traditional CPAP therapy because oral appliances are easy to use, comfortable, noise-free, portable, and do not require electricity or distilled water — all reasons why patient satisfaction and compliance are significantly higher with OAT than CPAP.

Covered by most health insurance plans, oral appliances are custom-made, delivered and adjusted by a qualified dentist trained to ensure proper fit and maximum effectiveness.

If you have questions or would like to learn more about what this means for you, please feel free to contact Dr. Charkhandeh 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.