Recall Z-1785-2025 ยท LLZ System, Image Processing, Radiological
Echopixel, Inc.
True 3D Viewer, Model: EP-00003
| Date | May 16, 2025 (initiated Feb 21, 2018) |
| Status | Open, Classified |
| Reason | With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound, and pre-operative analysis of surgical options), can result in incorrect display of image orientation, which could result in misdiagnosis or incorrect surgical treatment plan. |
| Root cause | Device Design |
| Action | On 2/21/2018, correction notices were emailed to customers who were asked to do the following: a) Affected software versions should not be used with Enhanced 3D Ultrasound DICOM compliant volumes or Philips 3DDCM. b) If clinicians are utilizing Enhanced 3D Ultrasound DICOM compliant volumes or Philips 3DDCM volume data sets, verify, retrospectively, any potential risk to health to patients and further determine if patients need to be reevaluated and report this information to the firm. c) Pass a copy of this notice to those staff members who need to be aware of the issue and maintain awarenes |
| Quantity | 18 |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL, CT, TX, LA, MI, MN and the country of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170167 | True 3D Viewer Software Echopixel, Inc., Mar 3, 2017 |