Recall Z-1807-2025 ยท LLZ System, Image Processing, Radiological
Echopixel, Inc.
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
| Date | May 21, 2025 (initiated Apr 11, 2016) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | On 03/25/2026, the firm sent via email and telephone an Urgent Field Safety Notice, informing customers of a potential misdiagnosis or incorrect surgical treatment planning approach can result when utilizing Enhanced Multi-frame DICOM image data sets. Customers were instructed to: verify if Enhanced Multi-Frame CT DICOM files have been used with the software. If users have utilized this file type, we request that users verify retrospectively any potential risk to health of patients and further determine if this patient needs to be reevaluated and report it to EchoPixel, Inc. We request that t |
| Quantity | 9 systems |
| Distribution | Worldwide - U.S. Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142107 | ECHO TRUE 3D VIEWER Echopixel, Inc., Jan 21, 2015 |