Recall Z-1785-2025— Echopixel, Inc.
Class II · Ongoing
Class II FDA medical device recall by Echopixel, Inc., initiated 2018-02-21. It names one FDA 510(k) clearance: K170167. Product: True 3D Viewer, Model: EP-00003. 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..
- Recalling firm
- Echopixel, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-02-21
- Firm location
- San Jose, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
True 3D Viewer, Model: EP-00003
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.