The Recall Desk
HighFDA (Devices)·Z-0889-2021·Announced 2021-02-03

Philips Respironics V60 Ventilator Recall for Backup Battery Failure Risk

Respironics is recalling 46,313 V60 Ventilators worldwide due to a risk of backup battery failure 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. The hazard involves a critical life-support device (ventilator) where battery failure poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Respironics California, LLC is recalling 46,313 units of the Philips Respironics V60 Ventilator (Part Number 1053617). 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 in the United States and numerous international markets. The ventilators are intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Specific serial numbers for the affected units are listed in the official recall documentation.

Consumers and healthcare facilities should check their device serial numbers against the list provided by the manufacturer or the FDA. If a device is affected, users should contact Respironics for instructions on how to proceed with the recall and any necessary corrective actions.

The recalled product

Product
Philips Respironics V60 Ventilator Part Number 1053617 - 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
46,313

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 (2)

  • Model: V60 Ventilator
  • Part Number 1053617 V60 Ventilator

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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