Class 2 Device Recall Philips Respironics V680 Ventilator

• Date Initiated by Firm: November 02, 2020
• Date Posted: January 22, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0917-2021
• Recall Event ID: 86697
• 510(K)Number: K082660
• Product Classification: Ventilator, continuous, minimal ventilatory support, facility use - Product Code MNT
• Product: Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
• Code Information: Model: V680 Part Number: 850011 V680 Ventilator, Finished Serial Numbers: 201009427 201009428 201009429 201009493 201009494 201009495 201009496 201009498 201009499 201009660 201009661 201009662 201009663 201009664 201009665 201009666 201009667 201009668 201009669 201009670 201009671 201009672 201009673 201009675 201009676 201009677 201009678 201009679 201009674 201008743 201008765 201008766 201008770 201008771 201008776 201008785 201008786 201008805 201009497 201008801 201008741 201008744 201008760 201008764 201008767 201008768 201008772 201008775 201008783 201008808 201008762 201008773 201008781 201008809 201008807 100124645 100124646 100125009 100125011 100125012 100125013 100125014 100125148 100125149 100125150 100125152 100125153 100125154 100125155 201008740 201008742 201008774 201008777 201008802 201008804 100125541 100125544 201008780 201008800 201008803 100125504 100125505 100125509 100125512 100125542 100125545 100125550 100125551 100125552 201008784 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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: 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: 3,453 systems
• 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