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Terminated

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 Recall Z-2071-2014 · Posted 2014-07-17

Recalling FirmSiemens Healthcare Diagnostics Inc
Recall StatusTerminated
Product CodeJQP
Date Initiated2014-05-22
Date Terminated2015-05-26
Product Quantity6 systems

Reason for Recall

RAPIDComm 5.0 Screen Layout will display incorrect test names

Firm Action

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.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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