Z-2631-2023Class I

Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617...

Name: Z-2631-2023 Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617...
Creator: Philips Respironics, Inc.
Published: 2023-08-25
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2023-08-25 / Open, Classified / root cause: manufacturing process

FDA source

Philips Respironics, Inc. began a recall of Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines) on 2023-08-25. FDA classified it as Class I and gives the reason as "Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2631-2023
Classification: Class I
Status: Open, Classified
Initiated: 2023-08-25
Posted: 2023-09-28
Recalling firm: Respironics, Inc.
Product: Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
Product code: MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Reason for recall: Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
Root cause tag: manufacturing process
FDA 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 in commerce: 15 (14 US; 1 OUS)
Distribution: US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2631-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2631-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-10-04	2023-09-28

Product code MNT

K102985Class IIV60 Ventilator with Ppv and Auto-Trak+ Software OptionsRespironics, Inc. / cleared 2011-04-05

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)