Z-1652-2009

Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version: 2.11 or less

Name: Z-1652-2009 Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version: 2.11 or less
Creator: Hitachi Medical Systems America Inc
Published: 2009-04-14
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2009-04-14 / Terminated / root cause: software

FDA source

Hitachi Medical Systems America Inc began a recall of Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version: 2.11 or less on 2009-04-14. The reason FDA records is "Incorrect scale on image: A software error can occur if two (2) different Field-of-View (FOV) settings are registered in a protocol using Multi-Reconstruction. This could cause the image generated to be displayed with...". 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-1652-2009
Status: Terminated
Initiated: 2009-04-14
Posted: 2009-07-07
Terminated: 2012-09-21
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version: 2.11 or less.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Incorrect scale on image: A software error can occur if two (2) different Field-of-View (FOV) settings are registered in a protocol using Multi-Reconstruction. This could cause the image generated to be displayed with the wrong scale factor rendering anatomical measurements incorrect.
Root cause tag: software
FDA root cause: Software design
Action: HMSA issued an URGENT - DEVICE CORRECTION notification to their customers on 4/14/2009. The notification describes the potential software error and the condition under which these image distortions can occur. The notification goes on to provide the customer with a work-around procedure which they can use to avoid encountering this issue with their current software configuration(s). The letter states that the firm will be installing updated software on all affected systems beginning in June, 2009, and that a Hitachi Service Rep. will be contacting each customer and making arrangements to come out and install a software upgrade on the affected system(s) at no cost to the customer. Lastly, the letter provides a telephone # to the firm's Applications Helpline: 1-877-228-2777, which the customer can use to obtain additional information, if desired.
Quantity in commerce: 4 units
Distribution: Nationwide distribution, including Puerto Rico (PR).
Product codes and lots: The recalled ECLOS system units are identified with the following Code Numbers: E1014, E5003 through E5005

Product code JAK

K071806Class IIEclos Computed Tomography X-Ray SystemHitachi Medical Systems America, Inc. / cleared 2007-08-28

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)