Siemens Healthcare recalls Atellica IM 1600 Analyzers with Material Number 11066000 due to software issues requiring an update. Affected units may need correction to prevent potential errors.
There were multiple issues identified in the system software which required an update.
Siemens Healthcare is recalling Atellica IM 1600 Analyzers with Material Number 11066000 because of software issues that require an update. This recall is to prevent potential errors in test results.
The system software had multiple issues that require an update. If not corrected, these software problems could lead to inaccurate test results. This is a low-risk issue that does not involve immediate physical danger.
Healthcare facilities using the Atellica IM 1600 Analyzer with Material Number 11066000 are likely affected. Laboratory staff and medical professionals who use the device are at risk of potential test errors.
Check for the Material Number 11066000 on the Atellica IM 1600 Analyzer. The device also has a unique identifier (UDI) starting with 00630414002026.
Verify the software version on your Atellica IM 1600 Analyzer to confirm if an update is needed.
No, the recall is for software issues that require an update to prevent potential test errors. It does not pose a risk of injury or serious harm.
Check for the Material Number 11066000 on the Atellica IM 1600 Analyzer. The device also has a unique identifier (UDI) starting with 00630414002026.
No, you can continue using the analyzer after updating the software to prevent potential errors.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1300-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1300-2019 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.
