Siemens Healthcare recalls Atellica IM 1300 analyzers with software v1.23.2 or lower that may report inaccurate patient test results. Affected units include those with specific material numbers.
Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
Siemens Healthcare is recalling Atel:lica IM 1300 analyzers that have software versions 1.23.2 or older. These versions may cause inaccurate patient test results, which could lead to incorrect medical diagnoses.
The software issues in versions 1.23.2 and lower can cause the analyzer to report incorrect patient test results. This may lead to wrong medical decisions if the results are used for diagnosis or treatment.
Healthcare facilities using the Atellica IM 1300 analyzer with software v1.23.2 or lower are affected. Laboratory staff and patients who receive tests from these devices may be at risk of inaccurate results.
Check if your Atellica IM 1300 analyzer has software version 1.23.2 or lower. The product uses Siemens Material Number (SMN) 11066001.
Contact Siemens Healthcare to update the software to version 1.23.3 or higher.
No, you can continue using it but you must update the software to version 1.23.3 or higher to fix the issue.
Software versions 1.23.2 and lower are affected.
Check the software version in your Atellica IM 1300 analyzer's 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-0862-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0862-2021 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.
