FDA recall Z-0271-2020

Product

Hitachi Scenaria Whole-body X-ray CT System

Reason for recall

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.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2019-10-16

Report date

2019-11-13

Termination date

2020-04-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Twinsburg, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0271-2020