Philips PAP, CPAP & Mechanical Ventilator Recall [US]


Philips Bi-Level PAP, CPAP & Ventilator Recall [US]

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US FlagUS/Silver Spring: Royal Philips, an Amsterdam, Netherlands establishment, recalls certain batch/lots of various Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (“CPAP”) and other Mechanical Ventilator Devices from the American marketplace to address identified potential health risks related to the Polyester-based Polyurethane (“PE-PUR”) Sound Abatement Foam component in these devices, a serious health and safety hazard requiring medical intervention.

FDA: http://ht.ly/hMkQ30rL0GE

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/philips-issues-recall-notification-mitigate-potential-health-risks-related-sound-abatement-foam

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Bi-Level PAP, CPAP and Ventilators are subject to this recall:

  • CPAP and BiLevel PAP Devices – All affected devices manufactured before 26 April 2021: all device serial numbers:
    • Continuous Ventilators, Minimum Ventilatory Support, Facility Use
      • E30
    • Continuous Ventilators, Non-life Supporting
      • DreamStation ASV
      • DreamStation AVAPS
      • SystemOne ASV4
      • C Series AVAPS/ST
      • OmniLab Advanced Plus In-Lab Titration Device
    • Non-continuous Ventilators
      • SystemOne (Q series)
      • DreamStation CPAP, Auto CPAP, BiPAP
      • DreamStation GO CPAP, APAP
      • Dorma 400 CPAP and Dorma 500 CPAP
      • REMStar SE Auto CPAP
  • Mechanical Ventilators – All affected devices manufactured before 26 April 2021, all device serial numbers:
    • Continuous Ventilators
      • Trilogy 100 Ventilator
      • Trilogy 200 Ventilator
      • Trilogy 200 Garbin Plus, Aeris, LifeVent Ventilator
    • Continuous Ventilators, Minimum Ventilatory Support, Facility Use
      • A-Series BiPAP Hybrid A30 (this product is not marketed in US)
      • A-Series BiPAP V30 Auto Ventilator
    • Continuous Ventilators, Non-life Supporting
      • A-Series BiPAP A40 (this product is not marketed in US)
      • A-Series BiPAP A30 (this product is not marketed in US)

Please consult the photograph above for details of the assistive health device’s design and retail presentation. Additional images of the recalled Ventilator products can be found on the Web site above.

==> No barcodes, UPCs, item numbers, manufacturing date codes, production dates, expiry dates, regulatory approval designations, registration numbers, agency approval designations or other identification numbers were listed with this recall notification.

Except where noted, these Philips branded Ventilator were known to be marketed, distributed and sold in all US states although it is always possible these assistive products had wider distribution within the country. When in doubt, please contact the manufacturer for specific product information.

If you are concerned about distribution outside the United States, please contact the manufacturer for specific product information.

According to the FDA, Philips has received reports of possible patient impact due to foam degradation. The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects. As a result of this reported defect, you should consider the following in conjunction with your personal physician and healthcare team:

For patients using any of the recalled BiLevel PAP and CPAP Devices:
Discontinue use of your device and work with your physician or Durable Medical Equipment (“DME”) provider to determine the most appropriate options for continued treatment. To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in the recall notification.

For patients using any of the Life-Sustaining Mechanical Ventilator Devices:
Do not stop or alter your prescribed therapy until you have talked to your physician. Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks identified in the recall notification.

==> If you have a medical emergency, please contact 9-1-1, your closest hospital or emergency center equipped to properly treat headaches, inflammation, respiratory impairment and/or possible toxic and carcinogenic damage.

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US Centers for Disease Control and Prevention Coronavirus Tips___________________________________________________________

Philips is providing the relevant regulatory agencies with required information related to the launch and implementation of the projected correction. The company will replace the current sound abatement foam with a new material and has already begun the preparations, which include obtaining the relevant regulatory clearances. Philips aims to address all affected devices in scope of this correction as expeditiously as possible.

As part of the program, the first-generation DreamStation product families will be modified with a different sound abatement foam and shipped upon receipt of the required regulatory clearances. Philips’ recently launched next-generation CPAP platform, DreamStation 2, is not affected by the issue. To support the program, Philips is increasing the production of its DreamStation 2 CPAP devices, that are available in the US and selected countries in Europe.

If you have any further questions, comments or complaints about this recall, please contact your local Philips representative during normal business hours, Monday to Friday or on the Web at http://www.philips.com/SRC-update.

==> To see other recalls and notifications caused by suspected faulty and/or dangerous Philips Ventilators, please search for “ventilator” using the Search Box at the top of this page.

==> To see other recalls and notifications concerning Choking hazards, please search for “Choking” using the Search Box at the top of this page.

==> To see other recalls and notifications concerning Respiratory Impairment hazards, please search for “respiratory” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Royal Philips, please search for “Philips” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the DreamStation brand, please search for “DreamStation” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the OmniLab brand, please search for “OmniLab” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the Trilogy brand, please search for “Trilogy” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 14572-2021
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
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Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food or drug you purchased in the US [external: new window opens]:
==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

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E. & O. E.

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