—#127449

Product

Siemens RAPIDComm Data Management System. The RAPIDComm Data Management System manages the process of sending and receiving data from Siemens POC devices and hospital systems located in the hospital network,

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Serial Numbers: 4387, 3734, 4177, 4149, 3074, 4194

Why it was recalled

RAPIDComm 5.0 Screen Layout will display incorrect test names

Root cause (FDA determination)

Software design

Action the firm took

Siemens Healthcare issued an Urgent Field Safety Notice by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on May 22, 2014, both in the United States and elsewhere for communication with affected customers. This notice informs customers of the issue with the RAPIDComm Data Management System (Version 5.0.A software correction will be issued to address the problem. Please retain this letter with your laboratory records. Complete and return the Field Correction Effectiveness Check attached to this letter within 30 days. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions please call (781) 269-3000.

Recalling firm

Firm: Siemens Healthcare Diagnostics Inc
Address: 2 Edgewater Drive, Norwood, Massachusetts 02062

Distribution

Distribution pattern: Worldwide Distribution - US including the states of OR and PA., and the countries of Denmark and UK.

Timeline

Recall initiated: 2014-05-22
Posted by FDA: 2014-07-17
Terminated: 2015-05-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127449. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.