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Hitachi Medical Systems America Inc recalls Hitachi Scenaria Whole-body X-ray CT System
Recalled November 13, 2019 · FDA recall Z-0271-2020 · Hitachi Medical Systems America
Hazard
There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system. · FDA Class II
Units
39
Sold at
The devices were distributed to the following US states: CA, FL, GA, IA, IN, MD, MT, NC, NY, OH, OK, SD, TN, TX, WY, and PR. The products were distributed to the following foreign countries: Brazil and Mexico.
Description
There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system.
Product
Hitachi Scenaria Whole-body X-ray CT System
Manufacturer(s)
Hitachi Medical Systems America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →