Arkon Anesthesia Delivery System — Class I medical device recall Z-0072-2018
Terminated recall by Spacelabs Healthcare, Ltd., reported 2017-11-29, distributed nationwide. Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxyge
| Recall number | Z-0072-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare, Ltd., Hertford, N/A, United Kingdom |
| Recall initiated | 2017-10-11 |
| Classified | 2017-11-21 |
| Reported by FDA | 2017-11-29 |
| Terminated | 2018-03-12 |
| Distributed | Nationwide (US) |
| Quantity | 110 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10841522100017 |
| Model numbers | 99999 |
Product
Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. 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 Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent failure of the display unit that resulted in a blank screen without audible or visible alarms.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0072-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.