The Recall Desk
HighFDA (Devices)·Z-0892-2021·Announced 2021-02-03

Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

Respironics is recalling three V60 Ventilators due to potential backup battery failures caused by over-discharge or extended storage 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 involves a life-support medical device (ventilator) with a potential for battery failure, which poses a risk of harm to patients. No injuries or illnesses are reported in the source text, and the agency classification is Class II, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Respironics California, LLC is recalling three units of the Philips Respironics V60 Ventilator (Part Number R1053618). The recall involves specific serial numbers: 100039155, 100054624, and 100054738. The devices were distributed worldwide, including nationwide in the United States and in numerous international countries.

The recall is being issued because the ventilators may experience potential issues with backup battery failures. These failures 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 devices are intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Affected users should contact Respironics for further instructions on how to address the battery issue. The source text does not specify a particular consumer action such as stopping use immediately, but users should verify if their device matches the listed serial numbers.

The recalled product

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.
Manufacturer
Respironics California, LLC
Category
Medical Device — Ventilators
Hazard
Affected units
3

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 R1053618 V60 Ventilator
  • Japan Opt: CFLEX
  • AVAPS Serial Numbers: 100039155 100054624 100054738

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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