Z-0889-06

Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and processing...

Name: Z-0889-06 Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and processing...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2004-08-02
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2004-08-02 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and processing workstation, for CT images on 2004-08-02. The reason FDA records is "Due to a software deficiency that occurs in the combine mode, a patients image can be filmed over a different patients image". 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-0889-06
Status: Terminated
Initiated: 2004-08-02
Posted: 2006-05-19
Terminated: 2012-03-02
Recalling firm: Philips North America LLC
Product: Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and processing workstation, for CT images.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Due to a software deficiency that occurs in the combine mode, a patients image can be filmed over a different patients image.
Root cause tag: software
FDA root cause: Other
Action: Revised, corrected software has been shipped to consignees beginning June, 2004.
Quantity in commerce: 397 devices.
Distribution: The systems were installed at medical facilities located nationwide and worldwide.
Product codes and lots: All serial numbers. Software version 1.0 or 1.0.1

Product code LLZ

K012009Class IIMx8000 Idt CT SystemMarconi Medical Systems, Inc. / cleared 2001-09-13

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)