Z-1005-04

Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM...

Name: Z-1005-04 Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM...
Creator: Hitachi Medical Systems America Inc
Published: 2004-05-07
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2004-05-07 / Terminated / root cause: software

FDA source

Hitachi Medical Systems America Inc began a recall of Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W on 2004-05-07. The reason FDA records is "Due to a software anomaly, various patient images may be intermixed within a single patient folder, which may result in mis-diagnosis and delay in treatment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1005-04
Status: Terminated
Initiated: 2004-05-07
Posted: 2004-07-20
Terminated: 2008-11-01
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W.
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: Due to a software anomaly, various patient images may be intermixed within a single patient folder, which may result in mis-diagnosis and delay in treatment.
Root cause tag: software
FDA root cause: Other
Action: The firm notified their Field Service Personnel and end-users by letter on 5/7/04 and 5/25/04.
Quantity in commerce: 3 units
Distribution: The devices were shipped to consignees in OH, PA, WI.
Product codes and lots: Serial Numbers: SE15704205, SE16773210, and SE16935305.

Product code ITX

K013723Class IIModification to: Eub-6500 Diagnostic Ultrasound ScannerHitachi Medical Corp. / cleared 2002-02-06

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)