TRUE 3D VIEWER SYSTEM displays medical images with incorrect orientation
Echopixel's TRUE 3D VIEWER SYSTEM may display imaging data with incorrect orientation (left/right/superior/inferior/anterior/posterior), which could lead to inaccurate measurements during clinical use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a risk-of-harm medical device where incorrect image orientation could lead to inaccurate clinical measurements, with no reported illnesses or injuries explicitly stated in the source. This meets the High severity criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Echopixel, Inc. is recalling the TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX (software versions 1.0, 1.25, and 1.35). The system is designed for use by healthcare professionals to visualize and interact with CT and MRI imaging data to assist in clinical decision-making.
The TRUE 3D VIEWER SYSTEM may display imaging system data with an incorrect orientation, where the patient side is not correct (left, right, superior, inferior, anterior, or posterior). This orientation error may lead to inaccurate measurements.
The recall affects 9 systems distributed nationwide in California, Ohio, New Jersey, Pennsylvania, Massachusetts, Florida, and Canada. The affected serial numbers are: C2015-09-0001, C2015-09-0003, D2015-05-0002, C2015-06-0002, D2015-12-0004, C2015-08-0001, D2015-12-0005, C2015-09-0002, D2015-12-0001, C2016-01-0001, D2015-12-0002, C2015-12-0002, D2015-12-0003, and D2016-01-0002.
Healthcare providers who have received this device should contact Echopixel, Inc. for instructions on the recall.
The recalled product
- Product
- TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D…
- Manufacturer
- Echopixel, Inc.
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model Number EP-00001-XX with software versions 1.0
- 1.25
Distribution
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