FDA Medical Device Recalls (openFDA)
Philips Respironics, Inc.: Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
- Recall number
- Z-2631-2023
- Recalling firm
- Philips Respironics, Inc.
- Product
- Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
- Status
- Open, Classified
- Initiated
- 2023-08-25
- Posted
- 2023-09-28
- Terminated
- not on file
- Reason
- Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
- Root cause
- Nonconforming Material/Component
- Action
- Impacted customers were contacted via phone and email on August 25, 2023. Philips released an "Urgent Medical Device Correction" customer letter to make customers aware of the potential for a power failure leading to ventilator loss of function. Instructions to Customer Discontinue use of and quarantine these device(s) until you are contacted by a Philips Respironics representative to remove and/or replace the Power Management PCBAs in the affected device(s). Philips Respironics will contact you to coordinate a time to remove and/or replace the impacted component located within your device(s). If you need any further information or support with this issue, please contact your local Philips Respironics representative, or call the Philips Respironics Customer Care Solutions Center at 1 (800) 722-9377. ***Updated November 2023*** Customers of the additional impacted PCBAs were contacted via phone and email on November 3, 2023.
- Quantity
- 15 (14 US; 1 OUS)
- Distribution
- US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.
- Lot, serial or model codes
- V60 Device Serial # /PCBA Serial # 201019564 SC23120K8 201014394 SC23120NH 201017048 SC2312133 100246411 SC231116C 100246416 SC231117H 100085632 SC2311127 100013579 SC23110EV 100082334 SC2311138 ***Updated November 6, 2023*** 100423818 SC2311168 100293267 SC2312154 100006900 SC2311165 100006889 SC23110MF 201010175 SC231104X (Philippines) ***Updated July 23, 2024*** 100385387 SC231108T 201029990 SC2311055
- 510(k) numbers
- ["K102985"]
- 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