Philips Respironics V60 Ventilator (All Models, including:… recallZ-0907-2022 · Respironics California, LLC · initiated Feb 28, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Respironics California, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0907-2022
- Status
- Open, Classified
- Initiated by the company
- Feb 28, 2022
- Posted by the FDA
- Apr 18, 2022
- Recalling firm
- Respironics California, LLC
- Quantity
- 87,138 units
- Product code
- MNT
- FDA submissions
- K102985
- 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 description
Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)
Code information (models, lots, serial numbers)
All Lots & Serial Numbers. V60 UDI-DI: 00884838009844, 00884838009851, 00884838020054, 00884838025776, 00884838089280, 00884838090996.
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- Philips Respironics V60Respironics California, Inc. · Ventilator, Continuous, Minimal Ventilatory Support,Facility Use3 recalls30 deaths13,525 reports
- PHILIPS 1076716Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls1 death2,946 reports
- PHILIPS 1053614Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls4 deaths1,203 reports
- PHILIPS 1053613Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls1 death161 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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