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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 13, 2002
Date Posted September 12, 2003
Recall Status1 Terminated 3 on April 11, 2005
Recall Number Z-1223-03
Recall Event ID 26547
510(K)Number K983447  
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Easy Access PACS System with software Release 5, 6.2, or 7.2
Code Information To be provided
Recalling Firm/
Philips Medical Systems
22100 Bothell Everett Highway
Bothell WA 98041
For Additional Information Contact
Manufacturer Reason
for Recall
Potential display of an incorrect body part description on patient images.
FDA Determined
Cause 2
Action On 2/13/02 the firm issued a letter to their consignees. The letter provided a remedy to the situtaion.
Quantity in Commerce 46 units
Distribution The firm distributed units to 46 hospitals and medical centers located throughout the U.S.
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 = SECTRA-IMTEC AB