Siemens recalls Centaur XP/XPT interface modules with outdated firmware that may cause test results to be misassigned, affecting clinical decisions. Affected units include specific model versions sold with UDI 00630414596754.
The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical interpretations and clinical decisions.
Siemens is recalling certain Centaur XP/XPT interface modules that may cause test results to be incorrectly linked to sample IDs. This could lead to wrong clinical decisions if not fixed, but the risk is not immediate or severe.
The outdated firmware may incorrectly match test results to sample IDs. This could lead to wrong clinical decisions if the system misidentifies which sample corresponds to which test result.
Healthcare facilities using the Centaur XP/XPT systems with the affected firmware versions are most at risk. Patients and staff using these systems could face potential misinterpretation of test results.
Check for the model number CENa_3-1-0-1 and lower in the firmware. Affected units have a unique device identifier (UDI) starting with 00630414596754.
Verify the firmware version on the interface module; affected units have CENa_3-1-0-1 and lower.
The affected firmware versions are CENa_3-1-0-1 and lower.
Check the firmware version; affected units have CENa_3-1-0-1 and lower, and a unique device identifier (UDI) starting with 00630414596754.
No immediate stop is required; check the firmware version to determine if your unit is affected.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0193-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0193-2022 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.
