Siemens Healthcare recalls Atellica IM 1600 analyzers with software v1.23.2 or lower that may report inaccurate patient test results. Affected units should be checked for the specific software version.
Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
Siemens Healthcare is recalling Atellica IM 1600 analyzers with software version 1.23.2 or older because they might show incorrect patient test results. This could lead to wrong medical decisions if the device is used in clinical settings.
The software issues in versions 1.23.2 and lower may cause the device to report incorrect patient test results. This could lead to wrong medical decisions if the device is used in clinical settings. The risk is limited to specific software versions and does not involve physical harm.
Healthcare facilities using the Atellica IM 1600 analyzer with software version 1.23.2 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 1.23.2 or lower. The product uses Siemens Material Number (SMN) 11066000 for clinical testing.
Verify your Atellica IM 1600 analyzer's software version to see if it is 1.23.2 or lower.
Software versions 1.23.2 or lower are affected.
Check if your Atellica IM 1600 analyzer has software version 1.23.2 or lower, using Siemens Material Number (SMN) 11066000.
No action is needed if your device has software version 1.23.3 or higher.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0863-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0863-2021 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.
