Z-0892-2021Class II

Philips Respironics V60 Ventilator Part Number R1053618 -

Name: Z-0892-2021 Philips Respironics V60 Ventilator Part Number R1053618 -
Creator: Respironics California, LLC
Published: 2020-10-30
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2020-10-30 / Terminated / 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 2020-10-30. FDA classified it as Class II and gives the reason as "Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0892-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-30
Posted: 2021-01-22
Terminated: 2024-09-19
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: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Root cause tag: design
FDA root cause: Device Design
Action: On 10/30/2020, the firm sent an "URGENT-MEDICAL DEVICE CORRECTION" Notification Letter via priority mail informing customer that the Ventilators may experience two potential issues with the battery (see table below for additional information). 1. The ventilator may exhibit a high priority Check Vent: Battery Failed alarm if the battery is allowed to over discharge. 2. The battery may fail to charge if the ventilator is stored for an extended period of time without being plugged into AC power. If the ventilator exhibits a high priority Battery Failed alarm while connected to AC power, the V60 ventilator will annunciate an audible and visual alarm. The ventilator will continue to deliver prescribed therapy; however, the audible and visual alarm will continue until the device is powered down; therefore, the patient should be transferred to an alternate source of ventilation as soon as one becomes available. The hazard associated with transferring a patient to an alternate source of ventilation is a temporary loss of therapy leading to potential hypercarbia or hypoxemia (moderate). If AC power fails and the backup battery is not functioning, an audible and visual alarm will annunciate for at least two minutes. The ventilator will no longer be operative resulting in a total loss of therapy. The patient will require an alternate source of ventilation. The hazard associated with a ventilator shutdown is a total loss of therapy leading to potential hypercarbia or hypoxemia (severe). Customers are instructed: Follow the instructions in the V60 user manual and the instructions below to reduce any risk associated with potential battery issues. 1) Avoid allowing the ventilator battery to become completely discharged. Otherwise, the battery may become over-discharged and require long recharge times of up to 16 hours or more. The over-discharged condition may permanently damage the battery so that it is unable to recharge. To prevent the occurrence o
Quantity in commerce: 3 systems
Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE,NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of 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 Ventilator, 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-0892-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0885-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0886-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0887-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0888-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0889-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0890-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0891-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0892-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0893-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0894-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0895-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0896-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0897-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0898-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0899-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0900-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-22
Z-0901-2021	Class II	Terminated	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)