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 SRC.fieldaction.support@philips.com
- 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
SRC.fieldaction.support@philips.com.
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
SRC.fieldaction.support@philips.com
- 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
Également disponible en français
SOURCE Health Canada (HC)