Siemens recalls RAPIDPOINT 500 Blood Gas Systems that may show falsely high sodium levels when used with certain drugs, risking incorrect patient treatment.
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.
Siemens is recalling RAPIDPOINT 500 Blood Gas Systems that can give false high sodium readings when used with specific medications. This could lead to delayed diagnosis and improper treatment of sodium imbalances in patients.
The system may show falsely elevated sodium levels when used with Perhexiline Maleate or Atomoxetine Hydrochloride. This could cause healthcare providers to treat patients with hypernatremia when they actually have hyponatremia, delaying proper care.
Healthcare providers using the RAPIDPOINT 500 Blood Gas System for blood tests are most at risk. Patients receiving treatment based on these results may be affected.
Check for the model numbers 10492730, 10696855, 10696857, or 10697306 on the device. All units and software versions are affected.
Identify the model number on the RAPIDPOINT 500 Blood Gas System to confirm if it is affected.
Perhexiline Maleate and Atomoxetine Hydrochloride.
It could lead to delayed diagnosis and improper treatment of sodium imbalances, such as treating hypernatremia when hyponatremia is present.
The recall does not specify a remedy; users should check their device model and contact Siemens for guidance.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0423-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0423-2024 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
