Z-0094-04

Philips Odyssey FX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems

Name: Z-0094-04 Philips Odyssey FX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2003-09-15
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2003-09-15 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Philips Odyssey FX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems on 2003-09-15. The reason FDA records is "Due to a software anomaly, an incorrect patient name may be transmitted with image to Odyssey workstation". 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-0094-04
Status: Terminated
Initiated: 2003-09-15
Posted: 2003-11-06
Terminated: 2008-10-29
Recalling firm: Philips North America LLC
Product: Philips Odyssey FX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Due to a software anomaly, an incorrect patient name may be transmitted with image to Odyssey workstation.
Root cause tag: software
FDA root cause: Other
Action: The firm notified their affected consignees by letter on 9/15/2003. The customers were informed how to avoid the problem until a software upgrade is installed on the units.
Quantity in commerce: 1,334 units installed
Distribution: The systems were installed at medical facilities located nationwide and worldwide.
Product codes and lots: All serial numbers / all models.

Product code LLZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)