Class 2 Device Recall RAPIDPOINT 500e Blood Gas System

• Date Initiated by Firm: September 26, 2023
• Date Posted: December 01, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0423-2024
• Recall Event ID: 93240
• 510(K)Number: K113216
• Product Classification: Electrode, ion specific, sodium - Product Code JGS
• Product: RAPIDPOINT 500 Blood Gas System
• Code Information: Material No. 10492730, 10696855, 10696857, & 10697306; UDI-DI:00630414589169, 00630414590851, 00630414590868, & 00630414590844; All Units and Software Versions.
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics Inc; 2 Edgewater Dr; Norwood MA 02062-4637
• For Additional Information Contact: Customer Service; 877-229-3711
• Manufacturer Reason for Recall: There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The erroneous sodium levels with positive bias may lead to unrecognized hyponatremia and/or the inappropriate treatment of hypernatremia may lead to iatrogenic hyponatremia, resulted in a delay in patient diagnosis and optimal patient management.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm issued an Urgent Medical Device Correction notice on 9/26/2023 to customers asking that customers review the notice with the facility's Medical Director to determine the appropriate course of action for previously generated results, complete and return the Field Correction Effectiveness Check Form within 30 days, forward this notice to customers if your firm is a distributor, and retain the notification in your system's Operator's Guide and forward to those who may have received product. The Field Correction Effectiveness Check Form is to be returned via email to uscctsfcaecfax.team@siemens-healthineers.com or by fax to 312-275-7795. Questions are to be directed to your local Siemens Healthineers Technical Support Representative.
• Quantity in Commerce: 12,363 units
• Distribution: Domestic: Nationwide Distribution. Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Congo, Republic, Costa Rica, Cote dIvoire, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Fiji, Finland, France, French, Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Lesotho, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Martinique, Mexico, Moldova, Montenegro, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestinian Territory, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom Great Britain, Uruguay, & 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

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