CLASS II Device recall · Reported 13 Nov 2019 · FDA Enforcement Report

Hitachi Scenaria Whole-body X-ray CT System recalled

Hitachi Medical Systems America is recalling Hitachi Scenaria Whole-body X-ray CT System, distributed in 16 states. The recall was initiated on 16 Oct 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesScenaria units S5002-S5014, S5017-S5044

Quantity recalled39

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0271-2020
FDA event ID: 84133
Recalling firm: Hitachi Medical Systems America, Twinsburg, OH
Classification: Class II
Status: Terminated
Recall initiated: 16 Oct 2019
FDA classified: 1 Nov 2019
Reported: 13 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

16 Oct 2019	Recall initiated by company
1 Nov 2019	Classified by FDA	+16 days
13 Nov 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Hitachi Scenaria Whole-body X-ray CT System

Where it was distributed

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.

California Florida Georgia Iowa Indiana Maryland Montana North Carolina New York Ohio Oklahoma Puerto Rico South Dakota Tennessee Texas Wyoming

Questions about this recall

Is Hitachi Scenaria Whole-body X-ray CT System recalled?

Yes. Hitachi Medical Systems America recalled Hitachi Scenaria Whole-body X-ray CT System on 16 Oct 2019. The recall is Class II and its status is Terminated. Recall number Z-0271-2020.

Why was it 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.

Which lots are affected?

Scenaria units S5002-S5014, S5017-S5044

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Hitachi Medical Systems America

All 17

Reported	Class	Recall	Company	Reason	Where
31 Mar 2021Device	CLASS II	Ultrasonic pulsed doppler imaging system recalled	Hitachi Medical Systems America	Potency & Assay	Nationwide
26 Feb 2020Device	CLASS II	UST-2265-2 Probe recalled by Hitachi Medical Systems	Hitachi Medical Systems America	Other	8 states
29 Aug 2018Device	CLASS II	Hitachi Scenaria CT system recalled by Hitachi Medical Systems	Hitachi Medical Systems America	Device Malfunction	TX
25 Jul 2018Device	CLASS II	Hitachi Oasis MRI system recalled by Hitachi Medical Systems	Hitachi Medical Systems America	Foreign Material	Nationwide
7 Mar 2018Device	CLASS II	Ultrasound Transducer recalled by Hitachi Medical Systems	Hitachi Medical Systems America	Device Malfunction	21 states

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