Z-1415-05

Extended Brilliance Workspace using 1.x or 2.x software

Name: Z-1415-05 Extended Brilliance Workspace using 1.x or 2.x software
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2005-03-11
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2005-03-11 / Terminated / root cause: labeling and UDI

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Extended Brilliance Workspace using 1.x or 2.x software on 2005-03-11. The reason FDA records is "When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1415-05
Status: Terminated
Initiated: 2005-03-11
Posted: 2005-08-30
Terminated: 2012-03-02
Recalling firm: Philips North America LLC
Product: Extended Brilliance Workspace using 1.x or 2.x software.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm sent recall/field correction letters dated 3/11/05.
Distribution: The devices were distributed to consignees throughout the United States and to consigness located in Argentina, Austria, Bahama, Belarus, Belguim, Brazil, Canada, China, Chile, Columbia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, England, Finland, France, Greece, Germany, Hungary, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Lebanon, Libya, Mexico, Morocco, Netherlands, New South Wales, New Zealand, Norway, Panama, Phillipines, Portugal, Poland, Romania, Russia, South Africa, Singapore, Slovenia, Spain, Sri Lanka, Switzerland, Sweden, Taiwan, Thailand, Turkey and Venezuela.
Product codes and lots: All codes.

Product code JAK

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)