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Hospira Inc. recalls Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. Note
Recalled November 16, 2016 · FDA recall Z-0362-2017 · Hospira
Hazard
May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the processor stop, sound a 3 minute audible alarm from the backup buzzer and deactivate the couch screen and the automated loading/unloading of cassettes. Delay or interruption of therapy. · FDA Class II
Units
10897
Sold at
Worldwide Distribution - US (nationwide) and Canada
Description
May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the processor stop, sound a 3 minute audible alarm from the backup buzzer and deactivate the couch screen and the automated loading/unloading of cassettes. Delay or interruption of therapy.
Product
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
Manufacturer(s)
Hospira Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →