Class 2 Device Recall Philips Respironics V60 Ventilator

• Date Initiated by Firm: October 30, 2020
• Create Date: January 22, 2021
• Recall Status: Completed
• Recall Number: Z-0893-2021
• 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 R1076709 - 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 R1076709 V60 Ventilator, JAPAN OPT: CFLEX,AVAPS,AT+ Serial Numbers: 100065352 100065365 100065371 100065487 100065493 100067423 100067425 100067428 100067431 100067451 100068214 100069518 100070301 100070306 100070398 100070476 100070491 100070492 100070768 100070774 100070776 100070777 100070778 100070780 100070781 100070859 100070862 100070865 100070921 100070922 100070924 100070928 100070929 100070930 100070935 100070966 100070969 100070973 100070976 100070981 100071071 100071073 100071077 100071123 100071461 100071510 100071511 100072415 100072417 100072418 100072499 100072570 100072606 100072607 100072673 100072676 100072679 100072684 100072685 100072688 100072690 100072695 100074195 100075099 100075100 100075104 100075189 100075293 100075312 100075381 100078120 100078132 100078140 100078145 100078266 100078302 100078313 100078362 100078365 100078366 100078372 100079387 100080231 100080233 100080236 100080237 100080239 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• 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: 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: 3,213 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.