The Recall Desk
HighFDA (Devices)·Z-0902-2021·Announced 2021-02-03

Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects

Respironics is recalling 2,137 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 is classified as FDA Class II, and the defect involves a life-support device where erratic parameter changes pose a risk of harm, though no specific injuries or deaths are reported in the source text.

Plain-English summary

Respironics California, LLC is recalling 2,137 Philips Respironics V60 Ventilators (Part Number 1053613) due to potential issues with the navigation ring interface and liquid ingress. The recall was initiated because 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 units were distributed worldwide, including the United States (nationwide, Guam, and Puerto Rico) and numerous international locations. The ventilators are intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. An amendment to the recall on July 29, 2021, identified 12 U.S. systems specifically for faceplate replacement.

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 repair or replacement. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Philips Respironics V60 Ventilator Part Number 1053613 - 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

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 (15)

  • Model: V60 Part Number 1053613 V60 Ventilator
  • Intl Opt: CFLEX
  • AVAPS
  • PP US Serial Numbers: 100051959
  • 100051964
  • 100051967
  • 100051968
  • 100094219
  • 100094345
  • 100095647
  • 100095648
  • 100095649
  • 100097381
  • 100181618
  • 100228824

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 →

Related recalls

Same manufacturer · Respironics California, LLC

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Same hazard · malfunction

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