# FDA recall Z-0959-2023

> **Getinge Usa Sales Inc** · Class I · device recall initiated 2022-12-22.

## Product

Getinge Flow-i Anesthesia Systems  Flow-i C20, Part no. 6677200  Flow-i C30, Part no. 6677300  Flow-i C40, Part no. 6677400

## Reason for recall

Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.

## Distribution

US nationwide and Worldwide Distribution:  Domestic distribution to AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA, WV. Foreign distribution worldwide.

## Key facts

- **Recall number:** Z-0959-2023
- **Recalling firm:** Getinge Usa Sales Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-22
- **Report date:** 2023-02-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0959-2023

## Citation

> AI Analytics. FDA recall Z-0959-2023. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-0959-2023. Source: US FDA. Licensed CC0.

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