Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1460-2017 — 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

U.S. FDA — Device Enforcement · United Kingdom · 2017-02-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1460-2017
Date of alert: 2017-02-08
Country / jurisdiction: United Kingdom
Risk level: Class II
Risk type: recall
Brand: Del Mar Reynolds Medical, Ltd.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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