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U.S. Department of Health and Human Services

Class 1 Device Recall Philips Respironics V60 Plus Ventilator

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  Class 1 Device Recall Philips Respironics V60 Plus Ventilator see related information
Date Initiated by Firm February 28, 2022
Date Posted April 18, 2022
Recall Status1 Open3, Classified
Recall Number Z-0908-2022
Recall Event ID 89767
510(K)Number K102985  
Product Classification Ventilator, continuous, minimal ventilatory support, facility use - Product Code MNT
Product Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
Code Information All Lots & Serial Numbers
Recalling Firm/
Manufacturer
Respironics California, LLC
2271 Cosmos Ct
Carlsbad CA 92011-1517
For Additional Information Contact Philips Customer Service
1800-722-9377
Manufacturer 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.
FDA Determined
Cause 2
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. The communication contained the following: . 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MNT and Original Applicant = RESPIRONICS CALIFORNIA, INC.
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