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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Odyssey FX Workstations

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  Class 2 Device Recall Philips Odyssey FX Workstations see related information
Date Initiated by Firm September 15, 2003
Date Posted November 06, 2003
Recall Status1 Terminated 3 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 2		 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.
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