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-0900-2021
• 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 U1053617 - 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 U1053617 V60 Ventilator, USED ENGL OPT:CFLEX, AVAPS,PPV,AT+ Serial Numbers: 100260233 100269324 100259732 100259863 100012867 100013831 100019589 100025024 100025938 100026001 100026663 100027660 100027968 100030595 100037381 100042754 100049903 100057035 100062238 100063161 100065043 100065047 100072563 100073252 100073254 100074566 100075395 100075396 100075409 100076087 100078252 100078850 100079007 100081754 100082656 100084977 100088335 100090937 100092047 100092057 100092309 100092442 100092544 100092969 100093791 100094690 100094731 100097992 100098699 100099976 100100750 100100856 100101065 100101404 100101408 100105454 100106192 100106406 100106521 100106590 100106715 100106884 100109744 100110298 100110378 100110458 100110478 100110479 100110485 100110489 100110598 100110610 100110673 100112876 100114470 100114525 100116572 100118818 100119210 100120753 100120821 100121402 100121456 100121686 100121815 100125763 100125926 100129587 100129595 100130458 100133611 100136136 100136643 100136655 100141903 100146850 100146852 100147180 100147797 100149576 100149714 100153310 100158909 100160567 100160569 100165175 100166344 100172321 100173098 100173451 100173878 100174081 100174140 100176545 100179474 100179478 100180773 100182557 100187312 100188343 100189912 100191275 100192793 100193226 100194905 100195660 100195872 100195875 100195889 100195891 100195892 100195899 100195968 100195969 100195970 100195978 100196000 100196002 100196004 100196005 100196006 100196007 100196008 100196010 100196012 100196013 100196015 100196016 100196017 100196018 100196019 100196020 100196021 100196022 100196100 100196101 100196103 100196104 100196106 100196107 100196108 100196109 100196110 100196111 100196112 100196113 100196114 100196115 100196117 100196118 100196119 100196120 100196121 100196122 100196123 100196124 100196125 100196126 100196128 100196129 100196130 100196131 100196132 100196134 100196135 100196136 100196137 100196139 100196400 100196401 100196403 100196406 100196407 100196408 100196409 100196410 100196411 100196413 100196414 100196415 100196416 100196417 100196418 100196419 100196420 100196421 100196422 100196423 100196424 100196425 100196426 100196427 100196428 100196434 100196619 100219464 100219967 100221176 100223855 100224350 100224708 100224970 100226526 100230373 100232632 100236034 100236968 100238071 100238136 100239821 100241846 100244859 100246583 100248301 100249178 100251889 100252101 100252951 100254743 100254960 100256421 100256849 100263569 100269325 100278293 100279592 100280589 201000762 201000769 201000770 201001941 201002494 201004093 201004394 201005787 201007765 201008139 201009340 201009889 201009948 201010587 201011021 201013041 201013786 201014044 201015018 201015057 201015083 201015127 201015481 201017700 201021042 201021044 201023087 201023345 201024350 201024382 201024385 201024483 201024747 201026183 201027175 201027359 201028921 201029423 201029806 201029966 201029975 201030285 201030856 201031934 201031987
• 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: 292 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.