The Recall Desk
HighFDA (Devices)·Z-1137-2021·Announced 2021-03-03

Respironics Recalls 94 Philips Ventilator Batteries Due to Design Verification Issues

Respironics is recalling 94 Philips V60 ventilator batteries because they were shipped without proper design verification. The recall covers distribution across multiple U.S. states.

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. The hazard involves a medical device (ventilator battery) where a failure could result in harm, but the source text does not report any specific injuries, illnesses, or deaths, placing it in the High category per the rubric for risk-of-harm products without reported injury.

Plain-English summary

Respironics California, LLC is recalling 94 units of the Philips Battery, V60 14.4V, 11.0 Ah, 163 Wh (REF 1076374(1058272), LOT M94663-P1). The recall was initiated because unqualified "design verification" batteries were shipped to customers.

The affected batteries were distributed nationwide, including in the states of Florida, Georgia, Iowa, Illinois, Minnesota, Missouri, North Carolina, North Dakota, Ohio, Texas, and Utah. The product is intended for use with Respironics-recommended patient circuits, interfaces, humidifiers, and other accessories.

Consumers who possess these specific batteries should stop using them and contact Respironics for instructions on how to proceed. The recall is classified as Class II by the FDA.

The recalled product

Product
PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is 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 Battery
Hazard
Affected units
94

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)

  • Battery Model/Part Number: 1076374 Lot Code: M94663-P1

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Related recalls

Same manufacturer · Respironics California, LLC

See all →