Class 2 Device Recall Philips Odyssey FX Workstations

• Date Initiated by Firm: September 15, 2003
• Date Posted: November 06, 2003
• Recall Status: Terminated on October 29, 2008
• Recall Number: Z-0094-04
• Recall Event ID: 27429
• Product Classification: System, Image Processing, Radiological - Product Code LLZ
• Product: Philips Odyssey FX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.
• Code Information: All serial numbers / all models.
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Rd; Cleveland OH 44143
• For Additional Information Contact: Ms. Joy M. Sacmar; 800-538-8531
• Manufacturer Reason for Recall: Due to a software anomaly, an incorrect patient name may be transmitted with image to Odyssey workstation.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.