# FDA recall Z-1389-2022

> **GE Healthcare, LLC** · Class I · device recall initiated 2022-06-01.

## Product

GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.

## Reason for recall

There is a potential reversal of the O2 and air cylinder pressure transducer connections.

## Distribution

Worldwide Distribution. US nationwide,  Australia, Austria, Belgium, Bolivia, Brazil, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Italy, Japan, Kenya, Korea, Kuwait, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Uruguay.

## Key facts

- **Recall number:** Z-1389-2022
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-06-01
- **Report date:** 2022-07-27
- **Termination date:** 2024-10-21

- **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-1389-2022

## Citation

> AI Analytics. FDA recall Z-1389-2022. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-1389-2022. Source: US FDA. Licensed CC0.

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