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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmFebruary 13, 2002
Date PostedAugust 12, 2003
Recall Status1 Terminated 3 on January 12, 2005
Recall NumberZ-1128-03
Recall Event ID 26583
510(K)NumberK982769 
Product Classification System, Image Processing, Radiological - Product Code LLZ
ProductEasyWeb
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
ActionA letter dated 2/13/02 was issued to customers advising that a representative from the firm will install new software.
Quantity in Commerce28
DistributionThe firm distributed units to hospitals and medical centers located throughout the US.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
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