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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 August 12, 2003
Recall Status1 Terminated 3 on January 12, 2005
Recall Number Z-1128-03
Recall Event ID 26583
510(K)Number K982769  
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product EasyWeb
Code Information The firm assigns a ''site number'' to each device: Z1776, 86233, 86264, 83198, 86944, 85075, 85077, 85083, 85071, 85067, 10377, 85048, 86026, X1676, 83675, 86025, 87131, 87158, 82683, 84027, 84087, 84359, 86007, 84405, 85453, 83917, 85189, 83961
Recalling Firm/
Manufacturer		 Philips Medical Systems
22100 Bothell Everett Highway
Bothell WA 98041
For Additional Information Contact
425-487-7000
Manufacturer Reason
for Recall		 Potential for incorrect body part information
FDA Determined
Cause 2		 Other
Action A letter dated 2/13/02 was issued to customers advising that a representative from the firm will install new software.
Quantity in Commerce 28
Distribution The firm distributed units to hospitals and medical centers located 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 = MITRA IMAGING, INC.
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