Z-1078-06

Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT)

Name: Z-1078-06 Hitachi CXR-4 CT Computed Tomography X-ray System (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 CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT) on 2006-02-21. The reason FDA records is "The device has a software anomaly which affects the system's ability to create Multiplanar Reconstructions (MPR). Some images from the resulting series do not display correctly, or display at all, when MPR was run on...". 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-1078-06
Status: Terminated
Initiated: 2006-02-21
Posted: 2006-06-03
Terminated: 2008-11-13
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT)
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The device has a software anomaly which affects the system's ability to create Multiplanar Reconstructions (MPR). Some images from the resulting series do not display correctly, or display at all, when MPR was run on them.
Root cause tag: software
FDA root cause: Other
Action: Hitachi Medical Systems America, Inc. became aware of an intermittent problem in the Multi-planar Reconstruction process when covering long ranges that could result in blank frames in the displayed reconstructions. HMSA also discovered a second software-related problem with the 50mm scale displayed on filmed images. In cases where the image has been magnified before filming, the 50mm scale is not correctly sized to the magnified image. Software corrections have already been installed on all units in order to correct the first of these problems (MPRs). According to the firm''s Device Notification Letter issued on 2/21/2006, a second software upgrade [which the firm states address both issues] will be released on or before 2/27/2006 and this correction 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: 15 units
Distribution: The recalled MRI systems were distributed throughout the continental United States.
Product codes and lots: Serial Number: CXR46201-46213 PC 46002-36011

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)