Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1220-03

Calculator/ Data Processing Module for Clinical Use

CliniSys, Inc / initiated 2003-07-24 / Terminated / root cause: software

Misys Healthcare Systems began a recall of Calculator/ Data Processing Module for Clinical Use on . The reason FDA records is "Software Design Defect. Under certain conditions, results are removed". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1220-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
CliniSys, Inc
Product
Calculator/ Data Processing Module for Clinical Use
Product code
JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall
Software Design Defect. Under certain conditions, results are removed.
Root cause tag
software
FDA root cause
Other
Action
Public Safety Notice was issued to all all affected clients by facsmile on 7/24/2003.
Quantity in commerce
47
Distribution
Nationwide
Product codes and lots
Version 3.x