# FDA recall Z-2883-2020

> **GE Healthcare, LLC** · Class II · device recall initiated 2020-07-14.

## Product

CARESCAPE R860 Ventilator    The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Volume.

## Reason for recall

The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered.

## Distribution

Domestic Distribution: USA  International Distribution: Australia, Bahrain, Bermuda, Canada, Egypt, France, Germany, Honduras, India, Iraq, Italy, Lebanon, Mexico, Panama, Peru, Russia, Saudi Arabia, Singapore, South Africa, Spain, Taiwan and United Arab Emirates.

## Key facts

- **Recall number:** Z-2883-2020
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-14
- **Report date:** 2020-09-02
- **Termination date:** 2024-09-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2883-2020

## Citation

> AI Analytics. FDA recall Z-2883-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2883-2020. Source: US FDA. Licensed CC0.

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