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

Recall Z-1442-2014 — SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.

U.S. FDA — Device Enforcement · United Kingdom · 2014-03-10 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1442-2014
Date of alert
2014-03-10
Country / jurisdiction
United Kingdom
Risk level
Class I
Risk type
recall
Brand
Del Mar Reynolds Medical, Ltd.
Product category
device
Product type
Devices
Reported risk: The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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