Echopixel recalls True 3D Viewer model EP-00003 with certain software versions that may display ultrasound images incorrectly, risking misdiagnosis or incorrect surgery.
With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound, and pre-operative analysis of surgical options), can result in incorrect display of image orientation, which could result in misdiagnosis or incorrect surgical treatment plan.
Echopixel is recalling its True 3D Viewer model EP-00003 because specific software versions can display ultrasound images incorrectly, potentially leading to misdiagnosis or wrong surgical plans. This affects medical professionals using the device for imaging analysis.
The device may show ultrasound images in the wrong orientation when using certain software versions. This could lead to incorrect medical interpretations, such as misdiagnosis or improper surgical planning.
Medical professionals who use the True 3D Viewer for ultrasound imaging analysis are most at risk. The recall applies to specific software versions sold between February 2017 and January 2018.
Check if your True 3D Viewer has model EP-00003 and software versions listed in the release notes from February 2017 to January 2018.
Verify your software version matches the listed versions in the recall notice (1.6.1.3080.428 or later, or develop versions from 0.00.2695.422 onwards).
Software versions from 1.6.1.3080.428 (released April 13, 2017) through 0.00.3730.447 (released February 8, 2018) are affected.
The official notice does not specify what to do if you have the correct software version.
The recall record does not mention any remedy or fix for the software issue.
We’ve drafted a message you can send Echopixel to request your refund or repair — edit it as you like.
Subject: Recall Z-1785-2025 — Echopixel Echopixel Hello, I own a Echopixel that is covered by recall Z-1785-2025 from Echopixel. 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.
