The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0896-2021·Announced 2021-02-03

Philips Respironics V60 Plus Ventilator Recalled for Backup Battery Failure

Respironics is recalling 3,887 V60 Plus Ventilators because the backup battery may fail if over-discharged or stored without AC power.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 medical device (ventilator) with a potential failure mode (battery) that could impact patient safety, but the source text does not report any specific injuries, illnesses, or deaths, 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 3,887 units of the Philips Respironics V60 Plus Ventilator (Part Number 1137276). 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 across all U.S. states and territories, as well as in numerous international countries. 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 providers should check their device 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 with the recall and any necessary repairs or replacements.

The recalled product

Product
Philips Respironics V60 Plus Ventilator Part Number 1137276 - 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
3,887

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 Plus Ventilator
  • Part Number 1137276 V60 Plus 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 →

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