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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 Ventilatorsee related information
Date Initiated by FirmNovember 02, 2020
Date PostedJanuary 22, 2021
Recall Status1 Open3, Classified
Recall NumberZ-0912-2021
Recall Event ID 86697
510(K)NumberK082660 
Product Classification Ventilator, continuous, minimal ventilatory support, facility use - Product Code MNT
ProductPhilips Respironics V60 Ventilator Part Number 1076717 - 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: 1076717 V60 Ventilator, CHINA OPT: NONE  Serial Numbers: 100033299 100033300 100033301 100033302 100033303 100033304 100033305 100033306 100033308 100033309 100033310 100033311 100033312 100033313 100033314 100033315 100033316 100033317 100033318 100033319 100033320 100033321 100033322 100033323 100033562 100033563 100033564 100033565 100033566 100033567 100033568 100033569 100033570 100033571 100033572 100033573 100033574 100033575 100033576 100033577 100033578 100033579 100033580 100033581 100033582 100033583 100033584 100033585 100033586 100033587 100033588 100033589 100033590 100033591 100033592 100033593 100033594 100033595 100033645 100033646 100033647 100033648 100033649 100033650 100033651 100033652 100033653 100033654 100033730 100033731 100033732 100033733 100033734 100033735 100033736 100033737 100033738 100033739 100033740 100033741 100033742 100033743 100033744 100033745 100033746 100033747 100033748 100033749 100033750 100033751 100033752 100033753 100033754 100033756 100033757 100033758 100033759 100033762 100033894 100033897 100033898 100033910 100033912 100034502 100034503 100034504 100034505 100034506 100034507 100034508 100034509 100034510 100034511 100034512 100034513 100034514 100034515 100034516 100034517 100034518 100034520 100034521 100034522 100034523 100035774 100035775 100035776 100035777 100035905 100035906 100035908 100035916 100035917 100035920 100035921 100035922 100035923 100035924 100035925 100035927 100035928 100036020 100036021 100036022 100036038 100036039 100036040 100036041 100036042 100036043 100036044 100036045 100036046 100036089 100036090 100036091 100036092 100036093 100036095 100036135 100036136 100036137 100036138 100036139 100036140 100036141 100036142 100036144 100036145 100036146 100036148 100036149 100061636 100061639 201002856 201002857 201002858 201002859 201002920 201002921 201002922 201002923 201002924 201002925 201002926 201002927 201002928 201002929 201002930 201002931 201002932 201002933 201002934 201002935 201002936 201002938 201002939 201002940 201002941 201002942 201002960 201002961 201002962 201002963 201002964 201002965 201002968 201002969 201002970 201002971 201002972 201002973 201002974 201002975 201002983 201004069      
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 2		Device Design
ActionOn 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 Commerce216 systems
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = MNT
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