Reported Nov 13, 2019 · Terminated

Hitachi Scenaria Whole-body X-ray CT System

Hitachi Medical Systems America Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hitachi Medical Systems America Inc · 1959 Summit Commerce Park · Twinsburg, OH · 44087-2371

Is this the product you have?

  • Hitachi Scenaria Whole-body X-ray CT System
Lot codes and dates
    • Scenaria units S5002-S5014
    • S5017-S5044
Amount recalled
39

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Hitachi Medical Systems America Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 30, 2020 · Data as of Sep 19, 4:45 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.