Z-1957-2021Class I

A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum...

Name: Z-1957-2021 A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum...
Creator: Philips Respironics, Inc.
Published: 2021-06-14
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2021-06-14 / Open, Classified / root cause: design

FDA source

Philips Respironics, Inc. began a recall of A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use on 2021-06-14. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1957-2021
Classification: Class I
Status: Open, Classified
Initiated: 2021-06-14
Posted: 2021-07-15
Recalling firm: Respironics, Inc.
Product: A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
Product code: MNS Ventilator, Continuous, Non-Life-Supporting
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: Urgent Medical Device Recall letters were sent to customers starting 6/14/21. 1. Do not stop or alter your prescribed therapy until you have talked to your physician. Your physician may evaluate if the benefit outweighs the risks. 2. If your physician determines that you must continue using this device, use an inline bacterial filter. Your Instructions for Use has guidance on installation. 3. Register your device on www.philips.com/src-update or call 1-877-907-7508. An updated URGENT: Medical Device Recall notification letter was issued on 11/16/21. 1. Do not stop or change ventilator use until you have talked to your health care provider. If patients requiring a ventilator for life-sustaining therapy have no alternate, or therapy disruption is unacceptable, the HCP may determine if the benefit of continued use of these ventilator devices outweighs the potential risks identified in the recall letter. 2. Talk to your HCP about using an inline bacterial filter to help filter out foam particles. Instructions for Use has guidance on installation. At this time, the FDA does not have evidence of the safety and effectiveness of a filter for mitigating the foam risks, and evaluation is ongoing. Filters will not reduce exposure to chemicals from the PE-PUR foam. Filters may increase air flow resistance and affect ventilator performance. Monitor for accumulation of foam debris in the filter or resistance-related problems in the breathing circuit after filter placement. 3. Report any problems with a device through the FDA MedWatch Voluntary Reporting Form. 4. Register your device on the recall website www.philips.com/src-update with your device Serial Number, or call 1-877-907-7508. Devices should be serviced only by qualified technicians. There are no user serviceable parts. Attempts to remove the sound abatement foam may render the device permanently inoperative. Devices damaged due to foam removal attempts will not be able to be remediated.
Quantity in commerce: 8047
Distribution: Worldwide distribution including US Nationwide, Argentina, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Korea, and Latin America.
Product codes and lots: All Devices manufactured before 26 April 2021, All device serial numbers. Material Numbers 1111181 1111182 1111178 1140184 1135427 1143671

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1957-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1956-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-15
Z-1957-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-15
Z-1958-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-15

Product code MNS

K113053Class IIBIPAP a 30 Ventilatory Support SystemRespironics, Inc. / cleared 2012-02-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)