Echopixel, Inc. 2025-05-28 Health serious FDA
Health · FDA · Recall #FDA-Z-1807-2025
TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 … Recall
Issued May 28, 2025 · Echopixel, Inc.
In May 2025, Echopixel, Inc. recalled the TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements.
What you should do
- 1 Stop using TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Echopixel, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Echopixel, Inc.
- Category
- Health
- Recall date
- May 28, 2025
- Units affected
- Not reported
- Sold at
- Worldwide - U.S. Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL and the country of Canada.
- Recall number
- FDA-Z-1807-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Echopixel, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.