Caption Health recalls ultrasound software version 1.2.0 due to potential incorrect heart measurement calculations. Affected users should check their software version and contact the company for updates.
The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoEF) and image quality score (IQS) estimates.
Caption Health is recalling a specific version of their ultrasound imaging software that may produce inaccurate heart measurements. This could lead to incorrect medical assessments if used without correction.
The software version 1.2.0 includes unintended video frames that can cause incorrect automated heart measurements. This might lead to wrong conclusions about heart function during medical imaging.
Healthcare providers using Caption Health's ultrasound imaging software with version 1.2.0 are affected. Medical staff using this software for patient imaging may be at risk of inaccurate results.
Check if your ultrasound imaging software shows version 1.2.0 (1.2.0+85ela410). The recall applies to all products with this specific software version.
Verify your ultrasound imaging software version to see if it matches 1.2.0 (1.2.0+85ela410).
The recall indicates potential for incorrect heart measurements, but the official notice does not specify patient harm.
The official notice does not mention a fix or update process.
The official notice does not specify a remedy, so contact Caption Health directly for guidance.
We’ve drafted a message you can send Caption Health to request your refund or repair — edit it as you like.
Subject: Recall Z-2111-2021 — Caption Health Caption Health Hello, I own a Caption Health that is covered by recall Z-2111-2021 from Caption Health. 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.
