FDA-Device2014-04-23Class I
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Del Mar Reynolds Medical, Ltd.
Hazard
The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.
Sold states
USA Nationwide Distribution in the states of North Carolina and South Carolina
Affected count
16 units distributed in the US
Manufactured in
1-2 Harforde Ct., Foxholes, Business Park, Hertford, N/A, United Kingdom
Products
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1442-2014Don't want to check this manually?
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