Agency classClass IIOur severity:High FDA (Devices)·Z-0901-2021·Announced 2021-02-03

Philips Respironics V680 Ventilator Recalled for Backup Battery Failure Risk

Respironics is recalling 3,453 V680 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 is classified as FDA Class II, and the hazard involves a life-support device (ventilator) where battery failure poses a risk of harm, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Respironics California, LLC is recalling 3,453 units of the Philips Respironics V680 Ventilator (Part Number 850011). The recall is due to a potential issue with the backup battery, which may fail if it 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 units were distributed worldwide, including nationwide distribution across all U.S. states and territories. The source text does not specify a particular date range for distribution or specific facilities where the units were installed.

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

The recalled product

Product: Philips Respironics V680 Ventilator Part Number 850011 - 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: battery-failure
power-loss
Affected units: 3,453

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: V680 Ventilator
Part Number 850011 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 →

Same manufacturer · Respironics California, LLC

See all →

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Same hazard · battery failure