# FDA recall Z-1137-2021

> **Respironics California, LLC** · Class II · device recall initiated 2021-01-06.

## 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.

## Reason for recall

Due to unqualified "design verification" batteries being shipped to customers.

## Distribution

U.S. Nationwide distribution including in the states of FL, GA, IA, IA, IL. IL, MN, MO, NC, ND, OH, TX, TX and UT.

## Key facts

- **Recall number:** Z-1137-2021
- **Recalling firm:** Respironics California, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-01-06
- **Report date:** 2021-03-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1137-2021

## Citation

> AI Analytics. FDA recall Z-1137-2021. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-1137-2021. Source: US FDA. Licensed CC0.

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