The Recall Desk
HighFDA (Devices)·Z-0910-2021·Announced 2021-02-03

Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects

Respironics is recalling 3,213 V60 Ventilators worldwide due to navigation ring issues that may cause erratic parameter changes or inoperability.

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 life-support medical device where a defect could lead to erratic parameter changes or inoperability, posing a risk of harm to patients, but no injuries or illnesses have been reported.

Plain-English summary

Respironics California, LLC is recalling 3,213 Philips Respironics V60 Ventilators (Part Number R1076709) distributed worldwide, including the United States, Guam, and Puerto Rico. The recall addresses potential issues with the ventilator's navigation ring interface and liquid ingress.

The identified defects may cause the navigation ring to 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 recall.

Healthcare facilities and users should identify affected units by checking the serial numbers listed in the official recall notice. Users should contact Respironics for instructions on corrective actions or replacements.

The recalled product

Product
Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Affected units
3,213

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 (3)

  • Model: V60 Part Number: R1076709 V60 Ventilator
  • JAPAN OPT: CFLEX
  • AVAPS

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 →