FDA Medical Device Recalls (openFDA)
Philips Respironics, Inc.: BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169
- Recall number
- Z-1630-2021
- Recalling firm
- Philips Respironics, Inc.
- Product
- BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169
- Status
- Terminated
- Initiated
- 2021-04-06
- Posted
- not on file
- Terminated
- 2024-01-17
- Reason
- 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
- 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
- 4 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
- Lot, serial or model codes
- Serial Number: V306120599B37, V3061207124CF, V30612105753F, V306121267414
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MNT
- Firm FEI
- 2518422
- Firm city
- Murrysville
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28