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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Respironics V60 Ventilator

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  Class 2 Device Recall Philips Respironics V60 Ventilator see related information
Date Initiated by Firm October 30, 2020
Create Date January 22, 2021
Recall Status1 Completed
Recall Number Z-0892-2021
Recall Event ID 86646
510(K)Number K082660  
Product Classification Ventilator, continuous, minimal ventilatory support, facility use - Product Code MNT
Product Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Code Information Model: V60 Ventilator, Part Number R1053618 V60 Ventilator, Japan Opt: CFLEX,AVAPS  Serial Numbers: 100039155 100054624 100054738 
Recalling Firm/
Manufacturer		 Respironics California, LLC
2271 Cosmos Ct
Carlsbad CA 92011-1517
For Additional Information Contact
800-722-9377
Manufacturer Reason
for Recall		 Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
FDA Determined
Cause 2		 Device Design
Action On 10/30/2020, the firm sent an "URGENT-MEDICAL DEVICE CORRECTION" Notification Letter via priority mail informing customer that the Ventilators may experience two potential issues with the battery (see table below for additional information). 1. The ventilator may exhibit a high priority Check Vent: Battery Failed alarm if the battery is allowed to over discharge. 2. The battery may fail to charge if the ventilator is stored for an extended period of time without being plugged into AC power. If the ventilator exhibits a high priority Battery Failed alarm while connected to AC power, the V60 ventilator will annunciate an audible and visual alarm. The ventilator will continue to deliver prescribed therapy; however, the audible and visual alarm will continue until the device is powered down; therefore, the patient should be transferred to an alternate source of ventilation as soon as one becomes available. The hazard associated with transferring a patient to an alternate source of ventilation is a temporary loss of therapy leading to potential hypercarbia or hypoxemia (moderate). If AC power fails and the backup battery is not functioning, an audible and visual alarm will annunciate for at least two minutes. The ventilator will no longer be operative resulting in a total loss of therapy. The patient will require an alternate source of ventilation. The hazard associated with a ventilator shutdown is a total loss of therapy leading to potential hypercarbia or hypoxemia (severe). Customers are instructed: Follow the instructions in the V60 user manual and the instructions below to reduce any risk associated with potential battery issues. 1) Avoid allowing the ventilator battery to become completely discharged. Otherwise, the battery may become over-discharged and require long recharge times of up to 16 hours or more. The over-discharged condition may permanently damage the battery so that it is unable to recharge. To prevent the occurrence o
Quantity in Commerce 3 systems
Distribution Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, 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, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Afghanistan, Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Maldives, Mali, Malta, Mexico, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, ST. Pier Miquel, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, Wallis Futuna, and Zambia.
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.
510(K) Database 510(K)s with Product Code = MNT and Original Applicant = RESPIRONICS CALIFORNIA, INC.
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