RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 This system tes

FDA device recall Z-2479-2015 · posted 2015-08-28 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics Inc

Reason for recall

When both ports (Serial and Ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other port causing the data management system to include either: duplicate data, missing data, or data from a different patient.

Action taken

Siemens Healthcare issued Urgent Field Safety Notice sent by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on July 28, 2015, both in the United States and outside of the United States, for communication with affected customers. This notice informs customers of the issue with the RAPIDPoint 500 dual port LIS transmission feature. Users are informed to: If the system is currently set up with dual LIS transmission enabled, one of the ports (either Serial or Ethernet) needs to be disabled. Instruction provided with the notification. Customer to complete Field Effectiveness Check Form to confirm receipt of the notice. The resolution of this issue will be implemented in the next software release for the RAPIDPoint 500 system. If you have any questions, contact Siemens Customer Care Center or your local Siemens technical support representative. Please fax this completed Customer Care form to (312) 275-7795.

Root cause

Software design

Status

Terminated

Product code

KHP

Quantity affected

5241 units

Distribution

Worldwide Distribution - US (nationwide) Distribution and to the countries of : Albania, Algeria, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Bulgaria,Canada, Chi

Date initiated

2015-07-28

Date posted

2015-08-28

Date terminated

2017-02-17

Location

Norwood, MA

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