FDA-Device2019-11-13Class II
Hitachi Scenaria Whole-body X-ray CT System
Hitachi Medical Systems America Inc
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.
Sold states
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.
Affected count
39
Manufactured in
1959 Summit Commerce Park, N/A, Twinsburg, OH, United States
Products
Hitachi Scenaria Whole-body X-ray CT System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0271-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief