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Neusoft Medical Systems Co., Ltd. recalls NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
Recalled January 4, 2017 · FDA recall Z-0876-2017 · Neusoft Medical Systems
Hazard
The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume. · FDA Class II
Units
23 units
Sold at
US Distribution
Description
The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume.
Product
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
Manufacturer(s)
Neusoft Medical Systems Co., Ltd.
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →