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Lower risk Medical device recall · FDA · Published May 17, 2024

Siemens RAPIDPoint 500e Blood Gas Software 5.3: Capillary Sample Labeling Error

Siemens recalls software version 5.3 for RAPIDPoint 500e Blood Gas Systems. This version incorrectly labels capillary blood samples as arterial in lab systems, risking wrong diagnoses. Affected units include specific models sold in US, China, Japan, and ROW.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2214-2024Medical deviceSiemens Healthcare ›
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Contact the company

Recalling firmSiemens Healthcare Diagnostics Inc2 Edgewater Dr · Norwood, MA 02062-4637
✎ GovInfoNow plain-language explainer

Siemens is recalling software version 5.3 for its RAPIDPoint 500e Blood Gas System. This software error causes capillary blood samples to be incorrectly labeled as arterial in lab systems, which could lead to wrong medical diagnoses and treatment decisions. Read more at govinfonow.com/recall/55044-siemens-rapidpoint-500e-blood-gas-software-5-3-capillary-sample.

Source Summary by GovInfoNow · govinfonow.com/recall/55044-siemens-rapidpoint-500e-blood-gas-software-5-3-capillary-sample · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2214-2024

Cite this page

“Siemens RAPIDPoint 500e Blood Gas Software 5.3: Capillary Sample Labeling Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55044-siemens-rapidpoint-500e-blood-gas-software-5-3-capillary-sample. Based on FDA recall #Z-2214-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2214-2024%22&limit=1).

The FDA announced on May 17, 2024, that Siemens Healthcare Diagnostics Inc is recalling software version 5.3 for the RAPIDPoint 500e Blood Gas System due to a labeling error. This issue may cause capillary samples to be incorrectly identified as arterial in laboratory information systems, potentially leading to incorrect diagnoses.

How to tell if you have it

  • RAPIDPoint 500e Blood Gas System (USA), Siemens Material Number: 11416751
  • RAPIDPoint 500e Blood Gas System (China), Siemens Material Number: 11416752
  • RAPIDPoint 500e Blood Gas System (Japan), Siemens Material Number: 11416754
  • RAPIDPoint 500e Blood Gas System (ROW), Siemens Material Number: 11416755

The hazard

According to the FDA, software version 5.3 incorrectly labels capillary samples as arterial when displayed on the LIS. This error may lead to results being flagged according to an established arterial range, which could result in incorrect diagnoses and management decisions.

Context

GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. On Aug. 17, 2026, Siemens issued a recall for the Atellica CH RCRP Test due to the potential for falsely elevated results. On July 13, 2026, Beckman Coulter recalled the Emit 2000 Quinidine Assay because of unacceptable precision performance that may lead to erroneously elevated quinidine measurements. On July 6, 2026, Siemens recalled the Atellica CH Urine Albumin test due to risks of falsely depressed results for Urea Nitrogen and Enzymatic Hemoglobin A.

How to tell if you have this one

Check for software version 5.3 on your RAPIDPoint 500e Blood Gas System. Affected units include specific models sold in the US, China, Japan, and ROW with Siemens Material Numbers 11416751-11416755.

  • Brand
    Siemens Healthcare
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your RAPIDPoint 500e system's software version. If it is 5.3, it is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 5 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of FL, GA, LA, MI, NC and the countries of Chile, Costa Rica, France, Germany, Japan, Lebanon, Mexico, Netherlands, New Zealand, Poland, Spain, Turkey, United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Georgia, Louisiana, Michigan, North Carolina.

Recall timeline

FDA published this recall 47 days after the firm started it.

1. Firm started the recall: May 17, 202412. FDA classified it Class II: Jun 26, 202423. Published in FDA’s Enforcement Report: Jul 3, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using the system?

No. The issue only affects software version 5.3, and the system can be updated to a corrected version without stopping use.

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Where this comes from

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.

  • Official source: FDA Recall #Z-2214-2024 (May 17, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2214-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA