Open, Classified

RAPIDPOINT 500e Blood Gas System

FDA Recall Z-0422-2024 · Posted 2023-12-01

Recalling FirmSiemens Healthcare Diagnostics Inc

Recall StatusOpen, Classified

Product CodeJGS

Date Initiated2023-09-26

Product Quantity8,749 units

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K192240RAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc. · 2020-03-27

Official Source

View FDA Recall →

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