# FDA recall Z-2589-2018

> **Spacelabs Healthcare, Ltd.** · Class I · device recall initiated 2018-07-11.

## Product

Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and  Model #: 99999. This system includes a ventilator.     The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.

## Reason for recall

Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.

## Distribution

Worldwide Distribution: U.S (nationwide) to states of.: LA, NE, CO, WY, MT, NM, IN, ME, NY, IL, MA, TX, PA, PR; and countries  (OUS) of: PERU BOLIVIA, PANAMA, MALAYSIA, POLAND, IRELAND, MOROCCO, MEXICO, CANADA, UNITED KINGDOM, FRANCE, and CHINA, ECUADOR.

## Key facts

- **Recall number:** Z-2589-2018
- **Recalling firm:** Spacelabs Healthcare, Ltd.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-11
- **Report date:** 2018-08-22
- **Termination date:** 2024-03-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hertford, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2589-2018

## Citation

> AI Analytics. FDA recall Z-2589-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2589-2018. Source: US FDA. Licensed CC0.

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