Z-0909-2021Class II

Philips Respironics V60 Ventilator Part Number R1053618 -

Name: Z-0909-2021 Philips Respironics V60 Ventilator Part Number R1053618 -
Creator: Respironics California, LLC
Published: 2020-11-02
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2020-11-02 / Open, Classified / root cause: design

FDA source

Respironics California, LLC began a recall of Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient... on 2020-11-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0909-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-11-02
Posted: 2021-01-22
Recalling firm: Respironics, Inc.
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.
Product code: MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
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.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: Model: V60 Part Number: R1053618 V60 Ventilator, Japan Opt: CFLEX,AVAPS Serial Numbers: 100039155 100054624 100054738

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0909-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0902-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0903-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0904-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0905-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0906-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0907-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0908-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0909-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0910-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0911-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0912-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0913-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0914-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0915-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0916-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0917-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-03	2021-01-22

Product code MNT

K082660Class IIV60 Ventilator, Model V8000Respironics California, Inc. / cleared 2009-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)