The Recall Desk
HighFDA (Devices)·Z-0911-2021·Announced 2021-02-03

Philips Respironics V60 Ventilator Recalled for Navigation Ring Defect

Respironics is recalling 10,291 V60 ventilators worldwide due to a navigation ring that may fail 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, but no injuries or illnesses have been reported.

Plain-English summary

Respironics California, LLC is recalling 10,291 units of the Philips Respironics V60 Ventilator (Part Number 1076716) worldwide. The recall covers units distributed in the United States, including Guam and Puerto Rico, as well as numerous countries across Asia, Europe, Africa, and the Americas.

The recall is issued because the ventilator's 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 source text does not report any illnesses, injuries, or deaths associated with this defect.

Healthcare providers and consumers should identify affected units by checking the serial number against the list provided in the official recall notice. The source text does not specify a corrective action or contact information for the recall.

The recalled product

Product
Philips Respironics V60 Ventilator Part Number 1076716 - 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
Affected units
10,291

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: 1076716 V60 Ventilator
  • CHINA 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 →

Related recalls

Same manufacturer · Respironics California, LLC

See all →

Same hazard · malfunction

See all →