The Recall Desk
HighFDA (Devices)·Z-0914-2021·Announced 2021-02-03

Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects

Respironics is recalling 834 V60 ventilators because the navigation ring may malfunction or cause erratic parameter changes.

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 critical medical device (ventilator) where a malfunction could lead to incorrect settings or loss of function, representing a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

Respironics California, LLC is recalling 834 units of the Philips Respironics V60 Ventilator (Part Number 1137292). The recall is due to potential issues with the ventilator's navigation ring interface and liquid ingress.

The navigation ring may become inoperative or operate intermittently. Additionally, the navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments. The affected devices were distributed worldwide, including the United States, Guam, and Puerto Rico.

Healthcare providers and consumers 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.

The recalled product

Product
Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Affected units
834

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 Part Number: 1137292 V60 Ventilator
  • Intl Opt CFLEX

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 →