Class 2 Device Recall Xcelera

• Date Initiated by Firm: April 15, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on April 11, 2005
• Recall Number: Z-0973-04
• Recall Event ID: 28937
• 510(K)Number: K022788
• Product Classification: System, Image Processing, Radiological - Product Code LLZ
• Product: Xcelera System, image processing, radiological.
• Code Information: Part numbers: 9896 050 73251XC1.1L1 Software binder; 9896 050 73252XC1.1L1 Sofware binder + SP2
• Recalling Firm/ Manufacturer: Philips Medical Systems Sales & Service Region No. America; 22100 Bothell Everett Highway; Bothell WA 98041
• For Additional Information Contact: Sarah Baxter; 425-487-7665
• Manufacturer Reason for Recall: Potential for the image data to be erased from the long term archive.
• FDA Determined Cause: Other
• Action: On 4/15/04 the firm sent letters to customers advising of the problem and that a service representative will visit and conduct a software upgrade.
• Quantity in Commerce: 56 units
• Distribution: Devices were distributed to hospitals and medical centers throughout the US.
• 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.

• 510(K) Database: 510(K)s with Product Code = LLZ