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Terminated

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

FDA Recall Z-0093-04 · 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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003437ODYSSEY LX, MODEL 211320Philips Medical Systems (Cleveland), Inc. · 2001-02-02K964712PRISM XPVT SYSTEM (210823)Philips Medical Systems (Cleveland), Inc. · 1997-02-21

Official Source

View FDA Recall →

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

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