# FDA recall Z-0754-2020

> **GE Healthcare, LLC** · Class I · device recall initiated 2019-09-27.

## Product

CARESCAPE Respiratory Module E-sCO

## Reason for recall

Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.

## Distribution

US  OUS: Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Korea (Republic of), Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Peru, Poland, Republic of Serbia, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, and Unites Kingdom

## Key facts

- **Recall number:** Z-0754-2020
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-27
- **Report date:** 2020-01-22
- **Termination date:** 2023-09-26

- **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-0754-2020

## Citation

> AI Analytics. FDA recall Z-0754-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0754-2020. Source: US FDA. Licensed CC0.

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