Respironics California, LLC: Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Recall number

Z-0909-2021

Recalling firm

Respironics California, LLC

Product

Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Status

Open, Classified

Initiated

2020-11-02

Posted

2021-01-22

Terminated

not on file

Reason

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.

Root 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

3 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.

Lot, serial or model codes

Model: V60 Part Number: R1053618 V60 Ventilator, Japan Opt: CFLEX,AVAPS  Serial Numbers: 100039155 100054624 100054738

510(k) numbers

["K082660"]

PMA numbers

not on file

Product code

MNT

Firm FEI

2518422

Firm city

Carlsbad

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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