Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiPAP), and Mechanical Ventilators (2021-06-14)

Starting date:
June 14, 2021
Posting date:
June 23, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-75889

Last updated:

Affected Products 

  1. REMSTAR AUTO WITH SD CARD, A-FLEX, CANADA
  2. REMSTAR AUTO WITH HUMIDIFIER, WITH SD CARD, A-FLEX, CANADA
  3. RESTAR PLUS WITH SD CARD, C-FLEX, CANADA
  4. RESTAR PLUS WITH HUMIDIFIER, WITH SD CARD, C-FLEX, CANADA
  5. RESTAR PRO WITH SD CARD, C-FLEX +, CANADA
  6. RESTAR PRO WITH HUMIDIFIER, WITH SD CARD, C-FLEX +, CANADA
  7. BIPAP AUTO BI-FLEX, WITH HUMIIFIER, WITH SMARTCARD, CANADA
  8. BIPAP AUTO BI-FLEX, WITH SMARTCARD, CANADA
  9. BIPAP PRO BI-FLEX, WITH HUMIDIFIER, WITH SMARTCARD, CANADA
  10. BIPAP PRO BI-FLEX, WITH SMARTCARD, CANADA
  11. RESTART, WITH HUMIDIFIER, WITH SMARTCARD, CANADA
  12. RESTAR, WITH SMARTCARD, CANADA
  13. BIPAP AVAPS, C SERIES VENTILATORY SUPPORT SYSTEM-DOMESTIC
  14. BIPAP AVAPS, C SERIES VENTILAROTY SUPPORT SYSTEM-CORE PKG, DOMESTIC
  15. BIPAP ST, C SERIES VENTILATORY SUPPORT SYSTEM-CANADA
  16. BIPAP ST, C SERIES VENTILATORY SUPPORT SYSTEM-CORE PKG,DOMESTIC
  17. BIPAP ST, C SERIES VENTILATORY SUPPORT SYSTEM, CORE PKG, CANADA
  18. OMNILAB ADVANCED, DOMESTIC
  19. OMNILAB ADVANCED, DOMESTIC CORE
  20. BIPAP AUTOSV ADVANCED SYSTEM ONE
  21. DREAMSTATION CPAP
  22. DREAMSTATION AUTO BIPAP
  23. DREAMSTATIN BIPAP PRO
  24. DREAMSTATION CPAP PRO
  25. DREAMSTATION AUTO CPAP
  26. DREAMSTATION BIPAP AUTOSV, CA
  27. DREAMSTATION BIPAP AUTOSV, W/HUMIDIFIER, CA
  28. DREAMSTATION BIPAP AUTO SV W/HUMID/HEATED TUBE, CA
  29. BIPAP AVAPS VENTILATORY SUPPORT SYSTEM-CANADA
  30. BIPAP AVAPS VENTILATORY SUPPORT SYSTEM-CORE PKG, CANADA
  31. DREAMSTATION GO CPAP
  32. DREAMSTATION GO AUTO CPAP
  33. DREAMSTATION EXPERT
  34. DREAMSTATION GO CPAP WITH HUMIDIFIER, CANADA
  35. DREAMSTATION GO AUTO CPAP WITH HUMIDIFIER, CANADA

Reason

Philips has become aware of two (2) issues that may pose a risk for patients or users of Philips Respironics branded Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BIPAP), and Mechanical Ventilators:

  1. Philips has determined from user reports and testing that the Polyester-Based Polyurethane (PE-PUR) sound abatement foam used in Philips continuous and non-continuous ventilators may degrade under certain circumstances, and the degraded particles could potentially enter the air pathway of the device.  This issue affects Philips Respironics branded CPAP’s, Bi-Levels, and Mechanical Ventilators.
     
  2. The results of testing performed by Philips indicate that the PE-PUR sound abatement foam used in these devices may emit certain chemicals.  Our investigation to date indicates that this emission occurs during initial operation and may possibly continue throughout the device's useful life.

These issues impact all device product platforms manufactured with Polyester Polyurethane (PE-PUR) sound abatement foam.  There is no specific population of device serial numbers which are impacted.

Affected products

A. REMSTAR AUTO WITH SD CARD, A-FLEX, CANADA

Lot or serial number

All lots.

Model or catalog number
  • CA551S
  • CA561BT
  • CA561S
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

B. REMSTAR AUTO WITH HUMIDIFIER, WITH SD CARD, A-FLEX, CANADA

Lot or serial number

All lots.

Model or catalog number
  • CA551HS
  • CA561HBT
  • CA561HS
  • CA561NTBT
  • CA561NTS
  • CA561TBT
  • CA561TS
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

C. RESTAR PLUS WITH SD CARD, C-FLEX, CANADA

Lot or serial number

All lots.

Model or catalog number
  • CA251S
  • CA261S
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

D. RESTAR PLUS WITH HUMIDIFIER, WITH SD CARD, C-FLEX, CANADA

Lot or serial number

All lots.

Model or catalog number
  • CA251HS
  • CA261HS
  • CA261NTS
  • CA261TS
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

E. RESTAR PRO WITH SD CARD, C-FLEX +, CANADA

Lot or serial number

All lots.

Model or catalog number
  • CA451S
  • CA461BT
  • CA461S
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

F. RESTAR PRO WITH HUMIDIFIER, WITH SD CARD, C-FLEX +, CANADA

Lot or serial number

All lots.

Model or catalog number
  • CA451HS
  • CA461HBT
  • CA461HS
  • CA461NTBT
  • CA461NTS
  • CA461TBT
  • CA461TS
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

G. BIPAP AUTO BI-FLEX, WITH HUMIIFIER, WITH SMARTCARD, CANADA

Lot or serial number

All lots.

Model or catalog number
  • CA751HS
  • CA761HBT
  • CA761HS
  • CA761NTS
  • CA761TBT
  • CA761TS
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

H. BIPAP AUTO BI-FLEX, WITH SMARTCARD, CANADA

Lot or serial number

All lots.

Model or catalog number
  • CA751S
  • CA761BT
  • CA761S
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

I. BIPAP PRO BI-FLEX, WITH HUMIDIFIER, WITH SMARTCARD, CANADA

Lot or serial number

All lots.

Model or catalog number
  • CA651HS
  • CA661HBT
  • CA661HS
  • CA661NTS
  • CA661TBT
  • CA661TS
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

J. BIPAP PRO BI-FLEX, WITH SMARTCARD, CANADA

Lot or serial number

All lots.

Model or catalog number
  • CA651S
  • CA661S
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

K. RESTART, WITH HUMIDIFIER, WITH SMARTCARD, CANADA

Lot or serial number

All lots.

Model or catalog number

CA151HS

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

L. RESTAR, WITH SMARTCARD, CANADA

Lot or serial number

All lots.

Model or catalog number

CA151S

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

M. BIPAP AVAPS, C SERIES VENTILATORY SUPPORT SYSTEM-DOMESTIC

Lot or serial number

All lots.

Model or catalog number

1060485

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

N. BIPAP AVAPS, C SERIES VENTILAROTY SUPPORT SYSTEM-CORE PKG, DOMESTIC

Lot or serial number

All lots.

Model or catalog number

1061418

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

O. BIPAP ST, C SERIES VENTILATORY SUPPORT SYSTEM-CANADA

Lot or serial number

All lots.

Model or catalog number

CA1061421

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

P. BIPAP ST, C SERIES VENTILATORY SUPPORT SYSTEM-CORE PKG,DOMESTIC

Lot or serial number

All lots.

Model or catalog number

1061422

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

Q. BIPAP ST, C SERIES VENTILATORY SUPPORT SYSTEM, CORE PKG, CANADA

Lot or serial number

All lots.

Model or catalog number

CA1061423

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

R. OMNILAB ADVANCED, DOMESTIC

Lot or serial number

All lots.

Model or catalog number

1111122

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

S. OMNILAB ADVANCED, DOMESTIC CORE

Lot or serial number

All lots.

Model or catalog number
  • 1111123
  • 1111124
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

T. BIPAP AUTOSV ADVANCED SYSTEM ONE

Lot or serial number

All lots.

Model or catalog number
  • CA951HS
  • CA951S
  • CA961HS
  • CA961NTS
  • CA961S
  • CA961TS
  • CA961XHS
  • CA961XS
  • CA961XTS
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

U. DREAMSTATION CPAP

Lot or serial number

All lots.

Model or catalog number
  • CAX200H12
  • CAX200S12C
  • CAX200T12
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

V. DREAMSTATION AUTO BIPAP

Lot or serial number

All lots.

Model or catalog number
  • CAX700H12
  • CAX700H12C
  • CAX700H12W
  • CAX700S12
  • CAX700T12
  • CAX700T12C
  • CAX700T12W
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

W. DREAMSTATIN BIPAP PRO

Lot or serial number

All lots.

Model or catalog number
  • CAX600H12
  • CAX600H12C
  • CAX600H12W
  • CAX600S12
  • CAX600T12
  • CAX600T12C
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

X. DREAMSTATION CPAP PRO

Lot or serial number

All lots.

Model or catalog number
  • CAX400H12
  • CAX400H12C
  • CAX400H12W
  • CAX400S12
  • CAX400T12
  • CAX400T12C
  • CAX400T12W
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

Y. DREAMSTATION AUTO CPAP

Lot or serial number

All lots.

Model or catalog number
  • CAX500H12
  • CAX500H12C
  • CAX500H12W
  • CAX500S12
  • CAX500T12
  • CAX500T12C
  • CAX500T12W
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

Z. DREAMSTATION BIPAP AUTOSV, CA

Lot or serial number

All lots.

Model or catalog number

CAX900S12

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

AA. DREAMSTATION BIPAP AUTOSV, W/HUMIDIFIER, CA

Lot or serial number

All lots.

Model or catalog number

CAX900H12

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

AB. DREAMSTATION BIPAP AUTO SV W/HUMID/HEATED TUBE, CA

Lot or serial number

All lots.

Model or catalog number
  • CAX900T12
  • CAX900T12C
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

AC. BIPAP AVAPS VENTILATORY SUPPORT SYSTEM-CANADA

Lot or serial number

All lots.

Model or catalog number
  • CA1060486
  • CA1161X
  • CAX1130S12
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

AD. BIPAP AVAPS VENTILATORY SUPPORT SYSTEM-CORE PKG, CANADA

Lot or serial number

All lots.

Model or catalog number
  • CA1061419
  • CA1161XTS
  • CAX1130H12
  • CAX1130H12C
  • CAX1130H12W
  • CAX1130T12
  • CAX1130T12C
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

AE. DREAMSTATION GO CPAP

Lot or serial number

All lots.

Model or catalog number

CAG400S12

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

AF. DREAMSTATION GO AUTO CPAP

Lot or serial number

All lots.

Model or catalog number

CAG500S12

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

AG. DREAMSTATION EXPERT

Lot or serial number

All lots.

Model or catalog number
  • CAX501H12
  • CAX501H12C
  • CAX501T12
  • CAX5O1T12C
  • CAX5O1T12W
Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

AH. DREAMSTATION GO CPAP WITH HUMIDIFIER, CANADA

Lot or serial number

All lots.

Model or catalog number

CAG400H12

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES

AI. DREAMSTATION GO AUTO CPAP WITH HUMIDIFIER, CANADA

Lot or serial number

All lots.

Model or catalog number

CAG500H12

Companies
Manufacturer
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES