SpaceLabs Arkon Anesthesia Delivery System with Version 2 — Class I medical device recall Z-1442-2014
Terminated recall by Del Mar Reynolds Medical, Ltd., reported 2014-04-23, distributed nationwide. The System may go into a controlled failed state if a series of parameters on the user interface are activated
| Recall number | Z-1442-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Del Mar Reynolds Medical, Ltd., Hertford, N/A, United Kingdom |
| Recall initiated | 2014-03-10 |
| Classified | 2014-04-11 |
| Reported by FDA | 2014-04-23 |
| Terminated | 2014-08-20 |
| Distributed | Nationwide (US) |
| Quantity | 16 units |
Product
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Reason for recall
The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.
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-1442-2014. 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.