Z-1079-06

Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT)

Name: Z-1079-06 Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT)
Creator: Hitachi Medical Systems America Inc
Published: 2006-02-21
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2006-02-21 / Terminated / root cause: software

FDA source

Hitachi Medical Systems America Inc began a recall of Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT) on 2006-02-21. The reason FDA records is "The device has a software anomaly which causes blank images to be created during Multiplanar Reconstruction processing or results in an inherent filming error in which a reference scale is improperly sized". 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-1079-06
Status: Terminated
Initiated: 2006-02-21
Posted: 2006-06-03
Terminated: 2008-11-13
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT)
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The device has a software anomaly which causes blank images to be created during Multiplanar Reconstruction processing or results in an inherent filming error in which a reference scale is improperly sized.
Root cause tag: software
FDA root cause: Other
Action: Hitachi Medical Systems America, Inc. was informed of a software-related problem with the 50mm scale displayed on filmed images. This problem was reported to the firm by their Japanese manufacturer. In cases where the image has been magnified before filming, the 50mm scale is not correctly sized to the magnified image. The firm issued a Device Correctioin Notice to their customers on 2/21/2006. The notice concerns the referenced software problem which results in the resizing of the images, as well as a second previously discovered problem which results in blank multi-planer reconstructions (MPR''s). According to the Device Correction Notice, a software upgrade has already been installed on all of the units in order to correct the MPRs problem [Ref: RES #35081, Correction Removal Report #1528028-01/31/06-003-C] In response to the resizing issue, a second software upgrade [which the firm states address both issues] will be released on or before 2/27/2006, and this software upgrade will be performed by HMSA''s service personnel during each customer''s next scheduled PM. The Device Notification Letter also instructs the customers to call their Field Service Representatives or the HMSA Applications Helpline if they have any questions about the notice, or if any additional problems are encountered.
Quantity in commerce: 16
Distribution: The 16 devices were distributed to 11 states: Texas, Florida, Louisiana, Illinois, Connecticut, Ohio, Massachusetts, Wisconsin, Idaho, California, New Jersey
Product codes and lots: CXR46201-46214 PC46002-46011

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