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.
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