NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.
FDA Recall Z-1166-2013 · Posted 2013-04-23
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Recalling FirmPhilips And Neusoft Medical Systems Co., Ltd.
Recall StatusTerminated
Product CodeJAK
Date Initiated2013-03-04
Date Terminated2013-11-22
Product Quantity25 units
Reason for Recall
User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.
Firm Action
The firm, Neusoft Medical Systems Co., Ltd., sent an "URGENT DEVICE CORRECTION" NeuViz Dual and NeuViz 16 letter, dated Mar. 4, 2013, to their US consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to review this information with all members of their staff and retain a copy of the letter with the equipment Instruction For Use.
Customers with questions should contact the Service Support Department by email to [email protected]
Root Cause
Use error
Distribution Pattern
Nationwide distribution: USA including states of: California, Connecticut, North Carolina, Nebraska, Ohio, South Carolina, Texas, and Puerto Rico.
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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