Siemens Healthcare recalls Atellica IM 1600 analyzers with software version 1.14.2 or 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 1600 analyzers with software version 1.14.2 or older. These devices could produce incorrect test results if used without the software update, which might affect patient care.
The software issues in versions 1.14.2 and lower may cause the analyzer to produce incorrect test results. This could lead to misdiagnosis or inappropriate treatment decisions for patients.
Healthcare facilities using Atellica IM 1600 analyzers with software version 1.14.2 or lower are most at risk. Patients receiving tests from these devices could potentially receive inaccurate results.
Check if your Atellica IM 1600 analyzer has software version 1.14.2 or lower. The Siemens Material Number (SMN) is 11066000 for affected units.
Install the latest software version to correct the issues and ensure accurate test results.
The software issues in versions 1.14.2 and lower may cause incorrect test results, which could affect patient care.
The Siemens Material Number (SMN) is 11066000 for affected Atellica IM 1600 analyzers.
No, you can continue using the device but must update the software to prevent incorrect 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-0781-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0781-2019 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.
