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Class 2 Device Recall Philips |
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Date Initiated by Firm |
June 27, 2003 |
Date Posted |
August 12, 2003 |
Recall Status1 |
Terminated 3 on January 12, 2005 |
Recall Number |
Z-1125-03 |
Recall Event ID |
26514 |
510(K)Number |
K983447
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Product Classification |
System, Image Processing, Radiological - Product Code LLZ
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Product |
Easy Access Software releases 1.1, 5.2, 6.2 & 7.2 |
Code Information |
The firm utilizes a site # to identify the devices: 83966, 82846, 82847,82843, 82845, 82850, 82849, 82844, 102836, 76904, 103125, 103124, 102835, 100640, 101185, 76938, 85078, 76937, 85083, 85077, 76904, 86255, 87121, 87120, 87119, 84399, 10276, 85052, 86190, 86050, X1758, X1676, 84031, 83966, 86002, 86001, X1776, 84476, 84088, 83676, 85451, 84361, 76945, 87130, 86198, 10379 |
Recalling Firm/ Manufacturer |
Philips Medical Systems 22100 Bothell Everett Highway Bothell WA 98041
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For Additional Information Contact |
425-487-7000
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Manufacturer Reason for Recall |
If DICOM fields for body part, description or accession number are changed, change won't update on the EasyWeb client or hospital systems.
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FDA Determined Cause 2 |
Other |
Action |
On 6/25/03 the firm issued a letter dated 6/15/03 to the affected customers. The letter advises of the problem and advises the customer that the firm will install corrected software in affected units. |
Quantity in Commerce |
46 devices |
Distribution |
Devices were distributed to 23 hospitals and medical centers 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 and Original Applicant = SECTRA-IMTEC AB
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