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Terminated

RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.

FDA Recall Z-2479-2015 · Posted 2015-08-28

Recalling FirmSiemens Healthcare Diagnostics Inc
Recall StatusTerminated
Product CodeKHP
Date Initiated2015-07-28
Date Terminated2017-02-17
Product Quantity5241 units

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.

Firm Action

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

Distribution Pattern

Worldwide Distribution - US (nationwide) Distribution and to the countries of : Albania, Algeria, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Bulgaria,Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany,Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands. New Zealand, Norway, P.R. China, Peru, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, U.A.E., United Kingdom and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113216RAPIDPOINT 500 BLOOD GAS ANALYERSiemens Healthcare Diagnostics · 2012-05-03K110277RAPIDPOINT 405 NEONATAL BILIRUBINSiemens Healthcare Diagnostics · 2011-08-15K020616BAYER RAPIDPOINT 405 SYSTEMBayer Diagnostics Corp. · 2002-07-17K002738BAYER RAPIDPOINT 400 SYSTEMBayer Corp. · 2000-12-19

Official Source

View FDA Recall →

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

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