The Recall Desk
SevereFDA (Devices)·Z-2631-2023·Announced 2023-10-04

Philips Respironics V60 and V60 Plus Ventilators Power Management Failure Recall

Philips Respironics V60 and V60 Plus ventilators are recalled because their power management components may fail, causing complete loss of ventilator function. The FDA classified this as a Class I recall.

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: FDA classified this as Class I. Per the severity rubric, Class I recalls score 4 or higher. Because no illnesses or injuries are reported in the source, the score is 4 rather than 5.

Plain-English summary

Philips Respironics is recalling certain V60 and V60 Plus ventilators because their power management circuit board assemblies (PCBAs) may malfunction. If the PCBA fails, the ventilator will lose power and stop functioning.

This recall involves 15 units: 14 in the United States (Ohio, California, South Carolina, and Oregon) and 1 in the Philippines. Specific device and component serial numbers are identified in the FDA recall notice.

Patients and healthcare providers should contact Philips Respironics immediately if they have or are using one of the affected ventilators. The FDA has classified this as a Class I recall.

The recalled product

Product
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Ventilator
Hazard
  • power-failure
  • device-malfunction

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 (1)

  • 2024*** 100385387 SC231108T 201029990 SC2311055

Distribution

Distributed in 4 states:

  • CA
  • OH
  • OR
  • SC

Related recalls

Same category