fda
2 records
FDA Recall: Echopixel, Inc. — Class II
20250528
Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, | Product: TRUE 3D VIEWER SYSTEM Model Number EP-...
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FDA Device Recall: TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, a
2025-05-28
Class II — 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 ...
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