The Recall Desk
HighFDA (Devices)·Z-0899-2021·Announced 2021-02-03

Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

Respironics is recalling 481 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 is classified as FDA Class II, and the hazard involves a critical medical device (ventilator) where battery failure could lead to harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Respironics California, LLC is recalling 481 units of the Philips Respironics V60 Ventilator (Part Number DU1053617). The recall is due to potential issues with backup battery failures. These failures may 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 units were distributed worldwide, including nationwide distribution in the United States and in numerous countries across multiple continents. The source text does not specify the exact number of affected units in each specific region, only the total count of 481 systems.

Consumers and healthcare facilities should check their V60 Ventilator serial numbers against the list provided in the official recall notice to determine if their unit is affected. If a unit is affected, users should follow the instructions provided by Respironics for remediation or replacement to ensure patient safety.

The recalled product

Product
Philips Respironics V60 Ventilator Part Number DU1053617 - 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
481

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 DU1053617 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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