The Recall Desk
HighFDA (Devices)·Z-0888-2021·Announced 2021-02-03

Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

Respironics is recalling 330 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 life-support medical device (ventilator) where battery failure could lead to harm, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Respironics California, LLC is recalling 330 units of the Philips Respironics V60 Ventilator (Part Number 1053616). The recall is due to potential issues with the backup battery, which may fail 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 territories, as well as in numerous countries across Asia, Europe, Africa, the Americas, and Oceania. The source text does not specify the exact number of affected units in the U.S. versus international markets, nor does it list specific serial numbers in the narrative, though a list of serial numbers is provided in the structured data.

Consumers and healthcare facilities should check their V60 Ventilator serial numbers against the list provided in the official recall notice. If a device is affected, users should contact Respironics for instructions on how to proceed, which may include replacing the battery or the unit. The source text does not report any illnesses or injuries associated with this defect.

The recalled product

Product
Philips Respironics V60 Ventilator Part Number 1053616 - 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
330

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 1053616 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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