Siemens RAPIDComm Data Management System. The RAPIDComm Data Management System manages the process of sending and receiv

FDA device recall Z-2071-2014 · posted 2014-07-17 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics Inc

Reason for recall

RAPIDComm 5.0 Screen Layout will display incorrect test names

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.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

6 systems

Distribution

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

Date initiated

2014-05-22

Date posted

2014-07-17

Date terminated

2015-05-26

Location

Norwood, MA