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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/
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 2
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 and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
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