FDA Medical devices recall ·
TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0… recall
- Recall number
- Z-1807-2025
- Date
- (initiated April 11, 2016)
- Company / brand
- Echopixel, Inc.
780 Montague Expy Ste 305, San Jose, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 9 systems
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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 Viewer (t3D-Viewer) system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM image data to assist in clinical decision making. The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system.
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number EP-00001-XX with software versions 1.0, 1.25, and 1.35 UDI-DI Codes: 00851325007003 Serial Numbers: Field Products: 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 D2016-01-0002
Distribution
Worldwide - U.S. Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL and the country of Canada.
States: California Florida Massachusetts New Jersey Ohio Pennsylvania
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1807-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.