Date Initiated by Firm |
April 01, 2003 |
Date Posted |
June 05, 2003 |
Recall Status1 |
Terminated 3 on April 21, 2004 |
Recall Number |
Z-0920-03 |
Recall Event ID |
26266 |
Product Classification |
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
|
Product |
Misys Commercial Laboratory version 2.x thru 3.4.1 |
Code Information |
Versions 2.x through 3.4.1 |
Recalling Firm/ Manufacturer |
Misys Healthcare Systems 4801 E Broadway Blvd Tucson AZ 85711
|
For Additional Information Contact |
Mark Ellis 520-733-6403
|
Manufacturer Reason for Recall |
Urgent care STAT reports are not printing in a timely fashion.
|
FDA Determined Cause 2 |
Other |
Action |
Recall notifications were sent to users on April 1, 2003 in Product Safety Notice PSN-03-L16 by facsimile. |
Quantity in Commerce |
109 |
Distribution |
Nationwide and to Canada. |
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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