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.
Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software version, samples run in the capillary mode are incorrectly labeled as arterial when displayed on the LIS, leading to the potential for results to be flagged according to an established arterial range. Capillary sample results are correctly identified as capillary on both the RAPIDPoint 500e system display and the instrument printouts. The issue only affects the new software version 5.3 and only capillary sample mode is impacted. The inability to distinguish specimen sources for blood gas may lead to incorrect diagnoses and management decisions.
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.
The software version 5.3 incorrectly identifies capillary blood samples as arterial when displayed in lab systems. This causes results to be flagged using arterial ranges, which could lead to incorrect medical diagnoses and treatment decisions. Capillary samples are correctly labeled on the device itself but not in the lab system.
Healthcare facilities using the RAPIDPoint 500e Blood Gas System with software version 5.3 in the US, China, Japan, or ROW are affected. Medical staff handling blood gas tests are most at risk of incorrect diagnoses due to mislabeled samples.
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.
Verify your RAPIDPoint 500e system's software version. If it is 5.3, it is affected.
Software version 5.3 incorrectly labels capillary blood samples as arterial in lab systems, which could lead to wrong diagnoses and treatment decisions.
No. The issue only affects software version 5.3, and the system can be updated to a corrected version without stopping use.
Check for software version 5.3 on your RAPIDPoint 500e system. Affected units include specific models sold in the US, China, Japan, and ROW with Siemens Material Numbers 11416751-11416755.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2214-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2214-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
