RecallRadar

FDA Device recall Z-0892-2021

Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-…

On 2021-02-03 the FDA classified a Class II recall of Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-… by Respironics California, citing 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 peri….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0892-2021
ClassificationClass II
Statusterminated
Initiated2020-10-30
Published2021-02-03
Last updated2026-09-13 11:56 UTC
CompanyRespironics California
DistributionUS

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.

Reason

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.

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0892-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.