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Recall Observatory FDA recall evidence

Device product

A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use

Z-1957-2021

June 14, 2021

Class I

Product summary

Firm
Philips Respironics, Inc.
Event
Event 88071
Status
Ongoing
Classification
Class I
Quantity
8047
Official record key
device-enforcement:Z-1957-2021

Official wording

Reason: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

Code information: All Devices manufactured before 26 April 2021, All device serial numbers. Material Numbers 1111181 1111182 1111178 1140184 1135427 1143671

Distribution pattern: Worldwide distribution including US Nationwide, Argentina, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Korea, and Latin America.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.