The Recall Desk
HighFDA (Devices)·Z-0886-2021·Announced 2021-02-03

Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

Respironics is recalling 9,863 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a critical life-support device (ventilator) where battery failure poses a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Respironics California, LLC is recalling 9,863 units of the Philips Respironics V60 Ventilator (Part Number 1053614). The recall is due to potential issues with backup battery failures. These failures may occur if the battery is allowed to over-discharge or if the ventilator is stored for an extended period of time without being plugged into AC power.

The affected devices were distributed worldwide, including nationwide distribution in the United States and in numerous countries across Asia, Europe, the Americas, Africa, and Oceania. The ventilators are intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Consumers and healthcare facilities should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected. If a device is affected, users should contact Respironics for instructions on how to proceed, as the battery failure could compromise the device's ability to provide backup power during AC power outages.

The recalled product

Product
Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Manufacturer
Respironics California, LLC
Category
Medical Device — Ventilator
Hazard
Affected units
9,863

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model: V60 Ventilator
  • Part Number 1053614 V60 Ventilator
  • Intl Opt: CFLEX

Distribution

Distributed nationwide across the United States.

The notice also names 54 states specifically:

Part of a larger recall action

This product is one of 17 recalled by Respironics California, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

Related recalls

Same manufacturer · Respironics California, LLC

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Same hazard · battery failure

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