Spacelabs ARKON Anesthesia Workstation — Class II medical device recall Z-1771-2013
Terminated recall by Del Mar Reynolds Medical, Ltd., reported 2013-07-31, distributed in SC. Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrect
| Recall number | Z-1771-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Del Mar Reynolds Medical, Ltd., Hertford, N/A, United Kingdom |
| Recall initiated | 2013-06-07 |
| Classified | 2013-07-19 |
| Reported by FDA | 2013-07-31 |
| Terminated | 2013-08-29 |
| Distributed | SC |
| Countries outside the US | CA |
| Reason classes | software |
Product
Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation 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.
Reason for recall
Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs, a buzzer will activate and a yellow triangle will be displayed on the System Status Computer screen that alerts the user of this error.
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-1771-2013. 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.