RecallDepth

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,

Company
Siemens Healthcare Diagnostics Inc
Recall Initiated
May 22, 2014
Posted
July 17, 2014
Terminated
May 26, 2015
Recall Number
Z-2071-2014
Quantity
6 systems
Firm Location
Norwood, MA

Reason for Recall

RAPIDComm 5.0 Screen Layout will display incorrect test names

Distribution

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

Lot / Code Info

Serial Numbers: 4387, 3734, 4177, 4149, 3074, 4194

Root Cause

Software design

Action Taken

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.

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