Z-0422-2024Class II

RAPIDPOINT 500e Blood Gas System

Name: Z-0422-2024 RAPIDPOINT 500e Blood Gas System
Creator: Siemens Healthcare Diagnostics Inc
Published: 2023-09-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-09-26 / Open, Classified

FDA source

Siemens Healthcare Diagnostics Inc began a recall of RAPIDPOINT 500e Blood Gas System on 2023-09-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0422-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-26
Posted: 2023-12-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: RAPIDPOINT 500e Blood Gas System
Product code: JGS Electrode, Ion Specific, Sodium
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 root 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 [email protected] or by fax to 312-275-7795. Questions are to be directed to your local Siemens Healthineers Technical Support Representative.
Quantity in commerce: 8,749 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.
Product codes and lots: Material No. 11416751, 11416752, 11416754, & 11416755; UDI-DI: 00630414286150, 00630414286167, 00630414286174, & 00630414286143; All Units and Software Versions.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0422-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0422-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-06	2023-11-30
Z-0423-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-06	2023-11-30

Product code JGS

K192240Class IIRAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc. / cleared 2020-03-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)