Arkon Anesthesia Delivery System — Class II medical device recall Z-1460-2017
Terminated recall by Del Mar Reynolds Medical, Ltd., reported 2017-03-22, distributed nationwide. Spacelabs has received reports of the Arkon Anesthesia Delivery System, Model 99999, shutting down without war
| Recall number | Z-1460-2017 |
|---|---|
| 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 | 2017-02-08 |
| Classified | 2017-03-14 |
| Reported by FDA | 2017-03-22 |
| Terminated | 2017-10-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | BO, CA, CN, EC, FR, GB, IE, MA, MX, MY, NL, PA, PE, PL |
| Serial numbers | ARKN-000001, ARKN-000002, ARKN-000003, ARKN-000004, ARKN-000005, ARKN-000010, ARKN-000011, ARKN-000012, ARKN-000013, ARKN-000014, ARKN-000015, ARKN-000016, ARKN-000017, ARKN-000018, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029 and 376 more |
| Model numbers | 99999 |
Product
Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon Anesthesia Delivery System is designed to provide emergency oxygen, vaporized agent delivery and manual ventilation in the event of a power failure scenario. Clinicians are able to use Emergency O2 and manually ventilate the patient, providing gas and agent. However, the anesthesiologist will not have access to mechanical ventilation or ventilator monitoring.
Reason for recall
Spacelabs has received reports of the Arkon Anesthesia Delivery System, Model 99999, shutting down without warning. The power supply has failed in a way that does not trigger the normal on battery 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-1460-2017. 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.