The Recall Desk
HighFDA (Devices)·Z-0893-2021·Announced 2021-02-03

Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

Respironics is recalling 3,213 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power.

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 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 3,213 Philips Respironics V60 Ventilators (Part Number R1076709). The recall is due to a potential issue where the backup battery may fail. This failure can 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 other countries. The ventilators are intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Consumers should check their device serial numbers against the list provided in the official recall notice. If the device is affected, users should contact Respironics for instructions on how to proceed, as the battery failure could compromise the ventilator's ability to provide backup power.

The recalled product

Product
Philips Respironics V60 Ventilator Part Number R1076709 - 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
3,213

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 (4)

  • Model: V60 Ventilator
  • Part Number R1076709 V60 Ventilator
  • JAPAN OPT: CFLEX
  • AVAPS

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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