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Recall Observatory FDA recall evidence

Device product

Hitachi Scenaria Whole-body X-ray CT System

Z-0271-2020

October 16, 2019

Class II

Product summary

Firm
Hitachi Medical Systems America Inc
Event
Event 84133
Status
Terminated
Classification
Class II
Quantity
39
Official record key
device-enforcement:Z-0271-2020

Official wording

Reason: 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.

Code information: Scenaria units S5002-S5014, S5017-S5044

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.