# FDA recall Z-2253-2018

> **Draeger Medical, Inc.** · Class II · device recall initiated 2018-05-24.

## Product

Apollo Anesthesia Machine; Cat. no. 8605310    Product Usage:  Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent concentration and identification. It is an inhalation anesthesia machine for use in operating, induction, and recovery rooms. It can be used with rebreathing systems, semiclosed to virtually closed systems with low flow and minimal flow techniques, and non-rebreathing systems (with the Auxiliary Common Gas Outlet). It may be used with O2, N2O, and Air supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine. The Apollo is equipped with a compact breathing system, providing fresh-gas decoupling, PEEP, and pressure limitation. It has an electrically driven and elect

## Reason for recall

The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result  in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.

## Distribution

US Nationwide Distribution - Healthcare facilities in AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MD, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, WA, WI, and WV.

## Key facts

- **Recall number:** Z-2253-2018
- **Recalling firm:** Draeger Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-24
- **Report date:** 2018-06-27
- **Termination date:** 2020-05-12

- **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-2253-2018

## Citation

> AI Analytics. FDA recall Z-2253-2018. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2253-2018. Source: US FDA. Licensed CC0.

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