Siemens Healthcare recalls Atellica IM 1300 Analyzer software versions 1.14.2 and lower due to potential incorrect test results. Affected units may need software update to prevent inaccurate clinical testing.
Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH 930 Analyzer; Atellica¿ Sample Handler Prime
Siemens Healthcare is recalling Atellica IM 1300 Analyzers with software versions 1.14.2 and older because they may produce incorrect test results. This could lead to inaccurate clinical diagnoses if the software is not updated.
The software versions 1.14.2 and lower have multiple issues that could cause incorrect test results. This means clinical diagnoses might be inaccurate if the software is not updated to a newer version.
Healthcare facilities using Atellica IM 1300 Analyzers with software versions 1.14.2 or older are most at risk. Clinical labs that perform in vitro diagnostic testing on patient samples could be affected.
Check if your Atellica IM 1300 Analyzer has software version 1.14.2 or lower. The product uses Siemens Material Number (SMN) 1066001 for in vitro diagnostic testing of clinical specimens.
Download and install the latest software version from Siemens Healthcare to fix the issues.
No, but you should update the software to the latest version to prevent incorrect test results.
Software versions 1.14.2 and lower are affected.
Check the software version in your Atellica IM 1300 Analyzer settings or contact Siemens Healthcare for assistance.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0780-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0780-2019 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.
