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Terminated

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

FDA Recall Z-0094-04 · Posted 2003-11-06

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2003-09-15
Date Terminated2008-10-29
Product Quantity1,334 units installed

Reason for Recall

Due to a software anomaly, an incorrect patient name may be transmitted with image to Odyssey workstation.

Firm 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.

Root Cause

Other

Distribution Pattern

The systems were installed at medical facilities located nationwide and worldwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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