Class 2 Device Recall Siemens RAPIDPoint 500 system

• Date Initiated by Firm: July 28, 2015
• Date Posted: August 28, 2015
• Recall Status: Terminated on February 17, 2017
• Recall Number: Z-2479-2015
• Recall Event ID: 71840
• 510(K)Number: K002738 K020616 K110277 K113216
• Product Classification: Acid, lactic, enzymatic method - Product Code KHP
• Product: 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.
• Code Information: Units shipped between the dates Oct 2011 - June 2015 and within the serial range of 30003-37040 not inclusive.
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics Inc; 2 Edgewater Dr; Norwood MA 02062-4637
• For Additional Information Contact: 781-269-3000
• Manufacturer 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.
• FDA Determined Cause: Software design
• 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.
• Quantity in Commerce: 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, 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KHP; 510(K)s with Product Code = KHP; 510(K)s with Product Code = KHP