Siemens recalls RAPIDPOINT 500e Blood Gas Systems that may give false high sodium readings when used with Perhexiline Maleate or Atomoxetine Hydrochloride, 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 500e Blood Gas Systems that can show falsely high sodium levels when used with certain medications. This may lead to incorrect treatment decisions and delayed diagnosis of sodium imbalances in patients.
The system may report falsely elevated sodium levels when used with specific medications. This could cause healthcare providers to treat patients for hypernatremia when they actually have hyponatremia, or vice versa, leading to delayed diagnosis and improper treatment.
Healthcare providers using the RAPIDPOINT 500e Blood Gas System with Perhexiline Maleate or Atomoxetine Hydrochloride medications. Patients receiving blood tests with these systems are at risk of incorrect sodium level readings.
Check for the RAPIDPOINT 500e Blood Gas System with Material Numbers 11416751, 11416752, 11416754, or 11416755. All units and software versions are affected.
Identify if your RAPIDPOINT 500e Blood Gas System has Material Numbers 11416751, 11416752, 11416754, or 11416755.
Perhexiline Maleate and Atomoxetine Hydrochloride.
The recall states it may lead to delayed diagnosis and improper treatment, but does not specify a risk of serious injury.
Check for Material Numbers 11416751, 11416752, 11416754, or 11416755 on your RAPIDPOINT 500e Blood Gas System.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0422-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0422-2024 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.
