Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1236-2009

Cerner Bridge Medical Transfusion Administration and Specimen Collections, Versions 3.4.0, 3.4.1 and 3.4.2

Cerner Corporation / initiated 2009-01-19 / Terminated / root cause: software

Cerner Corp began a recall of Cerner Bridge Medical Transfusion Administration and Specimen Collections, Versions 3.4.0, 3.4.1 and 3.4.2 on . The reason FDA records is "Specimen labels printing incorrect patient demographics". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1236-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Cerner Corporation
Product
Cerner Bridge Medical Transfusion Administration and Specimen Collections, Versions 3.4.0, 3.4.1 and 3.4.2.
Product code
JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall
Specimen labels printing incorrect patient demographics.
Root cause tag
software
FDA root cause
Software design
Action
Cerner Corporation issued a "Priority Review Flash" dated January 15, 2009 via e-mail to consignees using the software. The letter described the violative nature of the software and explained the proper navigation controls needed to prevent further issues. Further questions should be addressed to Bridge Client Support at 1-800-786-0239.
Quantity in commerce
4
Distribution
Nationwide distribution to states of OH, NC, MO and MI.
Product codes and lots
Software Versions 3.4.0, 3.4.1 and 3.4.2.