Z-0608-2009

Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces...

Name: Z-0608-2009 Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces...
Creator: Hitachi Medical Systems America Inc
Published: 2008-11-05
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2008-11-05 / Terminated / root cause: software

FDA source

Hitachi Medical Systems America Inc began a recall of Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces cross-sectional images of he body at different angles. The... on 2008-11-05. The reason FDA records is "Software error: The device has a software error that can result in a condition where the displayed image orientation does not match the display orientation markers (right-left reversal)". 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-0608-2009
Status: Terminated
Initiated: 2008-11-05
Posted: 2009-01-08
Terminated: 2012-09-21
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces cross-sectional images of he body at different angles. The system reconstructs, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician and is intended for general purpose CT applications.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Software error: The device has a software error that can result in a condition where the displayed image orientation does not match the display orientation markers (right-left reversal).
Root cause tag: software
FDA root cause: Software design
Action: On 11/5/2008 Hitachi Medical Systems sent recall notification letters entitled "URGENT - DEVICE RECALL CORRECTION" to its customers informing them of the problem with the software. They stated that a Hitachi service representative will contact each customer to schedule a software upgrade. For further information, please contact Hitachi Medical Systems America Inc. by telephone at 330-425-1313.
Quantity in commerce: 42
Distribution: Nationwide Distribution --- including states of AZ, CA, DE, FL, ID, IL, IN, KS, KY, LA, MA, MO, NJ, NY, OH, OK, PA, PR, SC, TX, VA, and WI.
Product codes and lots: Serial numbers: CXR46202 through CXR46248 excluding CXR46207, CXR46208, CXR46215, and CXR46222.

Product code JAK

K040902Class IIHitachi PrestoHitachi Medical Systems America, Inc. / cleared 2004-04-21

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)