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U.S. Department of Health and Human Services

Class 2 Device Recall Xcelera

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  Class 2 Device Recall Xcelera see related information
Date Initiated by Firm April 15, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 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/
Philips Medical Systems Sales & Service Region No. America
22100 Bothell Everett Highway
Bothell WA 98041
For Additional Information Contact Sarah Baxter
Manufacturer Reason
for Recall
Potential for the image data to be erased from the long term archive.
FDA Determined
Cause 2
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 and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.