Date Initiated by Firm |
December 06, 2002 |
Date Posted |
January 30, 2003 |
Recall Status1 |
Terminated 3 on February 26, 2013 |
Recall Number |
Z-0497-03 |
Recall Event ID |
25238 |
Product Classification |
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
|
Product |
Reference Library Interface Version 5.3 |
Code Information |
Version 5.3 |
Recalling Firm/ Manufacturer |
Sunquest Information Systems 4801 E Broadway Blvd Tucson AZ 85711
|
For Additional Information Contact |
Mark Ellis 520-570-2000
|
Manufacturer Reason for Recall |
Software system defect resulting in incomplete patient results information.
|
FDA Determined Cause 2 |
Other |
Action |
Product Safety Notice, PSN-02-L31 will be faxed to all affected customers. The notice provides product users with a description of the problem, an effective workaround, and the estimated release of coding modifications to the software version impacted. |
Quantity in Commerce |
30 |
Distribution |
Nationwide |
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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