| Class 2 Device Recall |  |
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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LLZ
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