The Recall Desk
SevereFDA (Devices)·Z-0663-2022·Announced 2022-03-09

Philips Respironics V60 Plus Ventilators with Defective Adhesive Recalled

Respironics California is recalling 294 V60 Plus ventilators assembled with expired adhesive. The adhesive may fail, causing the bracket to loosen and damage capacitors, potentially stopping ventilation delivery.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity of 4 per the classification guidelines. Although no illnesses or injuries have been reported, the defect creates risk of complete loss of ventilation in a critical life-support device.

Plain-English summary

Respironics California is recalling 294 Philips Respironics V60 Plus ventilator systems (Model V60, Part Number 1138747). These units were assembled with expired adhesive on the capacitor motor driver PCB bracket component.

The expired adhesive may fail, causing the bracket to become loose. A loose bracket can damage the capacitors, potentially resulting in the ventilator stopping ventilation delivery to the patient. This failure could occur either with or without alarm notification.

The recalled systems were distributed across the United States, including Arkansas, California, Florida, Georgia, Indiana, Louisiana, Maryland, Missouri, New York, Pennsylvania, South Carolina, Tennessee, and Texas.

The potential for a ventilator to suddenly stop ventilation without notice represents a serious safety concern for patients dependent on these devices for respiratory support.

The recalled product

Product
Philips Respironics V60 Plus Ventilator Part Number 1138747
Manufacturer
Respironics California, LLC
Hazard
  • adhesive-failure
  • component-defect
  • loss-of-ventilation
  • silent-failure

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)

  • The Component of the Ventilators that is impacted is: N 1034132 BRACKET
  • CAPACITOR

Distribution

Distributed in 13 states:

  • AR
  • CA
  • FL
  • GA
  • IN
  • LA
  • MD
  • MO
  • NY
  • PA
  • SC
  • TN
  • TX