# FDA recall Z-0501-2022

> **Draeger Medical, Inc.** · Class II · device recall initiated 2021-12-16.

## Product

Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300

## Reason for recall

26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the hospital O2 Central supply pressure is not stable, the O2 fresh gas flow could deviate from the adjusted value. If the deviation is not noticed, insufficient oxygenation of the patient may occur.

## Distribution

US Nationwide distribution in the states of NY, PA, and WI.

## Key facts

- **Recall number:** Z-0501-2022
- **Recalling firm:** Draeger Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-16
- **Report date:** 2022-01-26
- **Termination date:** 2023-04-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Telford, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0501-2022

## Citation

> AI Analytics. FDA recall Z-0501-2022. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0501-2022. Source: US FDA. Licensed CC0.

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