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Open, Classified

Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)

FDA Recall Z-0907-2022 · Posted 2022-04-18

Recalling FirmRespironics California, LLC
Recall StatusOpen, Classified
Product CodeMNT
Date Initiated2022-02-28
Product Quantity87,138 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102985V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONSRespironics, Inc. · 2011-04-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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