Z-0271-2020Class II

Hitachi Scenaria Whole-body X-ray CT System

Name: Z-0271-2020 Hitachi Scenaria Whole-body X-ray CT System
Creator: Hitachi Medical Systems America Inc
Published: 2019-10-16
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2019-10-16 / Terminated / root cause: manufacturing process

FDA source

Hitachi Medical Systems America Inc began a recall of Hitachi Scenaria Whole-body X-ray CT System on 2019-10-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0271-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-16
Posted: 2019-11-01
Terminated: 2020-04-30
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Hitachi Scenaria Whole-body X-ray CT System
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An Urgent Medical Device Correction Notice dated 10/15/19 was sent to customers. Hitachi will inspect all heat controller units for Scenaria systems S5002-S5014 and S5017-S5044 to ensure that the cables and cable loop clamp are affixed as instructed and apply modifications as needed. We expect to begin this process in late October I early November 2019. This action will be implemented by Hitachi Service at no charge to you. Your Service Area Manager will contact you for scheduling. Please contact me if you need further information regarding this report. You can send any questions, comments or requests to [email protected].
Quantity in commerce: 39
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.
Product codes and lots: Scenaria units S5002-S5014, S5017-S5044

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0271-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0271-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-01

Product code JAK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)