The Recall Desk
HighFDA (Devices)·Z-0913-2021·Announced 2021-02-03

Philips Respironics V60 Plus Ventilator Recall Due to Navigation Ring Malfunction

The FDA is recalling the Philips Respironics V60 Plus Ventilator because its navigation ring may become inoperative or operate intermittently, potentially causing ventilator parameter values to change erratically during setup or adjustment.

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 with no reported injuries or deaths, but involves a risk-of-harm medical device where parameter instability could pose a safety concern. The hazard type relates to navigation ring failure and unpredictable parameter changes.

Plain-English summary

The FDA is recalling the Philips Respironics V60 Plus Ventilator (part number 1137276) because its navigation ring may become inoperative or operate intermittently, potentially causing ventilator parameter values to change erratically during setup or adjustment. This recall affects users worldwide who have received or are receiving this ventilator model. Consumers should contact their healthcare provider or follow manufacturer instructions for further guidance on managing the issue.

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.
Affected units
3,841

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 (1)

  • Model: V60 Plus Part Number: 1137276 V60 Plus Ventilator

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 16 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 16 products in this recall →