Class 2 Device Recall Philips Respironics V60 Ventilator

• Date Initiated by Firm: November 02, 2020
• Date Posted: January 22, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0902-2021
• Recall Event ID: 86697
• 510(K)Number: K082660
• Product Classification: Ventilator, continuous, minimal ventilatory support, facility use - Product Code MNT
• Product: Philips Respironics V60 Ventilator Part Number 1053613 - 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 Part Number 1053613 V60 Ventilator,Intl Opt: CFLEX,AVAPS,PP Serial numbers: 100029460 100086827 100106522 100125955 100173096 100173294 100173478 100173526 100173591 100173593 100173595 100174299 100174305 100174308 100190730 100252781 100252782 100252785 100304095 100304097 100304263 100304264 100304446 100304447 100304448 100304451 100304462 201022963 100190253 201024196 201025984 201025987 201025988 100176847 100176856 100252776 100315180 100315377 100315598 100315602 100315607 100315610 100315889 100350701 100361426 100363749 100370895 100375246 100044066 100074200 100074206 100074207 100085241 100085243 100085327 100102145 100102150 100102152 100102155 100114031 100118553 100118676 100118684 100119491 100120774 100138585 100138589 100146847 100146849 100147395 201008175 201008180 201008192 201008218 201008225 201008226 201013645 201013649 201013650 201014018 201014041 201014042 201014047 201031153 201031164 201031195 201031200 201031214 201031215 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201008185 201008230 201009337 201009339 201010599 201014978 201015059 201015061 201023059 201028002 201029728 201030728 201030884 201030940 201030942 201030947 201030952 201030961 201031063 201031068 201031074 201031161 201031193 201031196 201031201 201031204 201031205 201031206 201031212 201031213 201031217 201031444 201031446 201031447 201031448 201031449 201031450 201031452 201031454 201031455 201031458 201031520 201031527 201031528 201031531 201031532 201031535 201031538 Amended 07/29/2021: US Products that Faceplates will be replaced Model: V60 Part Number 1053613 V60 Ventilator,Intl Opt: CFLEX,AVAPS,PP US Serial Numbers: 100051959; 100051964; 100051967; 100051968; 100094219; 100094345; 100095647; 100095648; 100095649; 100097381; 100181618; 100228824
• Recalling Firm/ Manufacturer: Respironics California, LLC; 2271 Cosmos Ct; Carlsbad CA 92011-1517
• For Additional Information Contact: 800-722-9377
• Manufacturer Reason for Recall: Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
• FDA Determined Cause: Device Design
• Action: On 11/02/2020, the firm sent an "URGENT-MEDICAL DEVICE CORRECTION" Notification Letter via priority mail informing customer that the V60 Ventilators may experience two potential issues with the navigation ring interface (see table below for additional information). 1. The navigation ring may become inoperative or begin operating intermittently. 2. The navigation ring may not behave as expected, making it difficult for the user to change ventilator settings via the touchscreen. and if clinicians accept an incorrect setting and leaves the patient on the ventilator without responding to the resulting alarms, the patient could sustain serious injuries. Customers are instructed: 1. When cleaning V60 ventilators, do not allow cleaning agents to pool on the ventilator surfaces. This is especially important on the device interface. 2. Check setting changes before and after accepting the changes. 3. If the navigation ring becomes inoperative or operates intermittently during clinical use, use the touchscreen for all settings changes and navigation, and contact Philips to schedule service following clinical use. 4. If the navigation ring interferes with your ability to adjust therapy settings via touchscreen, remove the ventilator from service and contact Philips for repair. and to please review the following sections of the user manual: 1. Chapter 10: Care and maintenance. To prevent possible damage to the ventilator when cleaning, use only those cleaning and disinfecting agents listed, and do not drip or spray any liquids directly onto any ventilator surface. 2. Chapter 1: Warnings, cautions, and notes. During clinical use of the ventilator, monitor patients for changes in respiratory status with each ventilator setting adjustment. Use an external oxygen monitor to verify oxygen concentration, and have an alternative means of ventilation available whenever a ventilator is in use. Customers are also instructed to complete, sign and return the Acknowledgement and Receipt
• Quantity in Commerce: 2,137 systems (Amended on 07/29/2021 - 12 U.S. systems for faceplate replacement)
• Distribution: Worldwide distribution - US Nationwide including Guam and Puerto Rico; 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.
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