Z-1626-2021Class II

BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169

Name: Z-1626-2021 BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169
Creator: Philips Respironics, Inc.
Published: 2021-04-06
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2021-04-06 / Terminated / root cause: manufacturing process

FDA source

Philips Respironics, Inc. began a recall of BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169 on 2021-04-06. FDA classified it as Class II and gives the reason as "Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1626-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-06
Posted: 2021-05-21
Terminated: 2024-01-17
Recalling firm: Respironics, Inc.
Product: BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169
Product code: MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Reason for recall: Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: In April, 2021, Philips issued an Urgent Medical Device Removal notice to customers via letter notifying them that Philips determined that certain devices were built with motor assemblies that could contain non-conforming plastic material. ACTION TO BE TAKEN BY CUSTOMER / USER 1. Locate all impacted devices listed above immediately STOP USE. All impacted devices must be removed from service. Replace with a non-impacted device if it is being used by a patient. 2. This notice needs to be passed on to all those who must be aware within your organization or to any organization where the impacted devices have been transferred. 3. Once impacted devices have been removed from service and isolated notify your Philips Representative that the impacted devices are ready for return. Your Philips Representative will arrange for return of the device. Replacements will be provided free of charge. 4. Fill out the Business Reply Form that has been provided with this letter and return it to your Philips Representative. This form serves as official acknowledgement that you have fully performed your obligations to complete this medical device recall.
Quantity in commerce: 10 units
Distribution: Distribution US nationwide to states of: LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN. Brazil, China, and Japan
Product codes and lots: Serial Number: V30446637ACAE, V30446653BE5A, V304441360854, V304457587F98, V304468408502, V304441766F34, V3044555732D7, V30446846E034, V30444034719A, V3044642346EA.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1626-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1625-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-02	2021-05-21
Z-1626-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-02	2021-05-21
Z-1627-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-02	2021-05-21
Z-1628-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-02	2021-05-21
Z-1629-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-02	2021-05-21
Z-1630-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-02	2021-05-21

Product code MNT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)