Z-0908-2022Class I

Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)

Name: Z-0908-2022 Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
Creator: Respironics California, LLC
Published: 2022-02-28
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2022-02-28 / Open, Classified / root cause: design

FDA source

Respironics California, LLC began a recall of Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276) on 2022-02-28. FDA classified it as Class I and gives the reason as "Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate". 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-0908-2022
Classification: Class I
Status: Open, Classified
Initiated: 2022-02-28
Posted: 2022-04-18
Recalling firm: Respironics, Inc.
Product: Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
Product code: MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Reason for recall: Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.
Root cause tag: design
FDA root cause: Device Design
Action: On March 14, 2022, Respironics California, LLC issued an Urgent Medical Device Correction notification to all affected consignees. On April 28, 2022 Respironics issued a revised customer communication titled Update: Urgent Medical Device Correction, dated April 20, 2022, which described mitigating actions. On June 30, 2022, Respironics issued an Updated Urgent Medical Device Correction Notification. This letter was to provide customers with an update on Philips Respironics actions to address an issue related to the internal source (35V Rail) that powers the V60/V60 Plus ventilators. In addition, between the dates of January 23, 2023 - March 8, 2023, Respironics issued a "Field Safety Notice" to customers who own the V680 model. the notification informed customers that the device will be removed from the market. The communication contained the following listed below: To address the issue with the 35V Rail, Philips Respironics will be deploying a technical solution (changing two resistors within the ventilator) that will cause the V60/V60 Plus ventilators to alarm in all cases should it experience an issue with the 35V Rail. Philips Respironics will be contacting customers to schedule an appointment to implement the technical solution in your V60/V60 Plus ventilator(s) starting in October 2022. Philips Respironics is offering customers a loaner EV300 ventilator while the customer awaits deployment of the technical solution in its V60/V60 Plus ventilator(s) should it be unable to implement one of the mitigations provided in the April 2022 letter. All other information provided in the April 2022 customer communication is unchanged. This notice needs to be provided to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred.
Quantity in commerce: 12,145 units
Distribution: Worldwide distribution US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Afghanistan, Albania, Algeria, American Samoa, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Comoros, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Maldives, Mali, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland , Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, St. Pier, Miquel., Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Ukraine, United Kingdom, Utd. Arab. Emir., Venezuela, Vietnam, Wallis, Futuna, Zambia, Japan.
Product codes and lots: All Lots & Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0908-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0907-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-18
Z-0908-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-18
Z-0909-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-18

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)