Siemens Healthcare recalls Atellica CH 930 Analyzers with software version 1.14.2 or lower due to potential inaccurate test results. Affected units may need software update to prevent incorrect clinical diagnoses.
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 CH 930 Analyzers with software version 1.14.2 or older because of potential inaccurate test results. This could lead to incorrect clinical diagnoses if the software fails to properly process test samples.
The software issues in versions 1.14.2 and lower could cause inaccurate test results. This might lead to incorrect clinical diagnoses if the analyzer fails to properly process test samples, potentially affecting patient care.
Healthcare facilities using Atellica CH 930 Analyzers with software version 1.14.2 or lower are most at risk. Clinical labs and hospitals that perform in vitro diagnostic testing may be affected.
Check if your Atellica CH 930 Analyzer has software version 1.14.2 or lower. The product uses Siemens Material Number (SMN) 1 067000 for in vitro diagnostic testing of clinical specimens.
Verify your analyzer's software version; if it is 1.14.2 or lower, it is affected.
Contact Siemens Healthcare to update to a newer software version that resolves the issue.
Software versions 1.14.2 and lower are affected.
Check the software version on your Atellica CH 930 Analyzer; versions 1.14.2 or lower are affected.
No, but you should update the software to a newer version to prevent inaccurate test results.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0782-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0782-2019 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.
