CLASS II ONGOING Device recall · Reported 6 Dec 2023 · FDA Enforcement Report

Rapidpoint 500 Blood Gas System recalled

Siemens Healthcare Diagnostics is recalling Rapidpoint 500 Blood Gas System, distributed nationwide in the US. The recall was initiated on 26 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMaterial No. 10492730, 10696855, 10696857, & 10697306; UDI-DI:00630414589169, 00630414590851, 00630414590868, & 00630414590844; All Units and Software Versions.

Quantity recalled12,363 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0423-2024
FDA event ID: 93240
Recalling firm: Siemens Healthcare Diagnostics, Norwood, MA
Classification: Class II
Status: Ongoing
Recall initiated: 26 Sep 2023
FDA classified: 30 Nov 2023
Reported: 6 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

26 Sep 2023	Recall initiated by company
30 Nov 2023	Classified by FDA	+65 days
6 Dec 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

RAPIDPOINT 500 Blood Gas System

Where it was distributed

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.

Nationwide Georgia

Questions about this recall

Why was it recalled?

Which lots are affected?

Material No. 10492730, 10696855, 10696857, & 10697306; UDI-DI:00630414589169, 00630414590851, 00630414590868, & 00630414590844; All Units and Software Versions.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 93240

Reported	Class	Recall	Company	Reason	Where
6 Dec 2023	CLASS II	Rapidpoint 500e Blood Gas System recalled	Siemens Healthcare Diagnostics	Other	Nationwide

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