Class 2 Device Recall Xcelera R 1.2

• Date Initiated by Firm: December 21, 2004
• Date Posted: March 18, 2005
• Recall Status: Terminated on February 10, 2006
• Recall Number: Z-0640-05
• Recall Event ID: 30780
• 510(K)Number: K022788
• Product Classification: System, Image Processing, Radiological - Product Code LLZ
• Product: Xcelera R1.2 Cardiology image and information management solution software.
• Code Information: Xcelera Software version R1.2
• FEI Number: 1000524572
• Recalling Firm/ Manufacturer: Philips Medical Systems Sales & Service Region No. America; 22100 Bothell Everett Hwy; Bothell WA 98021
• For Additional Information Contact: Sarah Baxter; 425-487-7665
• Manufacturer Reason for Recall: Loss of image data from image repository and archive requiring patients to undergo repeat imaging.
• FDA Determined Cause: Other
• Action: The firm notified hospitals via letter sent 12/21/2004 stating the service organization will perform onsite upgrades.
• Quantity in Commerce: 33
• Distribution: 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