NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
FDA Recall Z-1650-2016 · Posted None
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Recalling FirmNeusoft Medical Systems Co., Ltd.
Recall StatusTerminated
Product CodeJAK
Date Initiated2015-05-02
Date Terminated2016-11-04
Product Quantity7 units
Reason for Recall
It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner position was set to "Right" in the system setting - scanner options.
Firm Action
An upgraded software version (1.0.5.2619+P11) was released on May 7, 2015.
The FCO was released to the service engineers of Neusoft Medical Systems USA, which is subsidiary of the reporting firm, and the engineers performed FCO for each affected device together with the distributors' engineers. The corrections (FCOs to upgrade software) on all the affected systems in the USA have been completed. At present (4/27/16) there is no longer this issue on the systems, so no further actions are needed for customers/distributors. However, the recalling firm shall inform the direct accounts of this fix before May 5, 2016. The recalling firm will submit the communication evidence ASAP once they have evidence of the communication. For further questions, please call (281) 453-1205.
Root Cause
Device Design
Distribution Pattern
US Distribution - Including Puerto Rico and the states of IL, CT, SC, NE
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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