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Del Mar Reynolds Medical, Ltd. recalls SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Recalled April 23, 2014 · FDA recall Z-1442-2014 · Del Mar Reynolds Medical
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. · FDA Class I
Units
16 units distributed in the US
Sold at
USA Nationwide Distribution in the states of North Carolina and South Carolina
Description
The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.
Product
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Manufacturer(s)
Del Mar Reynolds Medical, Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →