Arkon Anesthesia Delivery System with Arkon Software Version 2 — Class I medical device recall Z-2589-2018
Terminated recall by Spacelabs Healthcare, Ltd., reported 2018-08-22, distributed nationwide. Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine
| Recall number | Z-2589-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare, Ltd., Hertford, United Kingdom |
| Recall initiated | 2018-07-11 |
| Classified | 2018-08-10 |
| Reported by FDA | 2018-08-22 |
| Terminated | 2024-03-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | BO, CA, CN, EC, FR, GB, IE, MA, MX, MY, PA, PE, PL |
| Quantity | 328 |
| UPC / GTIN / UDI-DI | 10841522100017 |
| Serial numbers | ARKN-000001, 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, ARKN-000030 and 303 more |
| Model numbers | 99999 |
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.
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-2589-2018. 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.