Merge Healthcare recalls specific software versions due to potential inaccurate Z-Score calculations that could lead to false negative results in medical testing. Affected users should check their software versions and contact the company for guidance.
An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. The error may reduce the sensitivity of the Z-Score in detecting an abnormality resulting in a false negative.
Merge Healthcare is recalling certain software versions because an error in calculating Michigan Reference Ranges might cause inaccurate Z-Score results, potentially missing medical abnormalities. This could lead to incorrect health assessments if the software is used in clinical settings.
The software error can produce incorrect Z-Score calculations for medical testing, which might reduce the system's ability to detect abnormalities. This could result in false negative outcomes where a medical issue is not identified properly.
Healthcare providers using Merge Cardio Workstation Software versions 10.X and 11.X with specific Knowledge Base versions installed before February 21, 2020 are most at risk. These versions are used in clinical environments for processing medical data.
Check if your software includes Merge Cardio Workstation versions 10.X or 11.X with Knowledge Base versions 3.3, 3.4, 3.5, or 5.0 installed before February 21, 2020. The product codes (PN) listed in the recall details can help identify affected units.
Identify your software version by checking the product codes (PN) listed in the recall notice, such as 88-00528-00 for version 10.0.
Reach out to Merge Healthcare for guidance on whether your software version is affected and what steps to take next.
Merge Cardio Workstation Software versions 10.X and 11.X with Knowledge Base versions 3.3, 3.4, 3.5, or 5.0 installed before February 21, 2020.
Check your software version against the specific product codes (PN) listed in the recall notice, such as 88-00528-00 for version 10.0.
No action is required if your software version is not listed in the recall details.
We’ve drafted a message you can send Merge Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2403-2020 — Merge Healthcare Merge Healthcare Hello, I own a Merge Healthcare that is covered by recall Z-2403-2020 from Merge 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.
