True 3D Viewer, Model: EP-00003

FDA device recall Z-1785-2025 · posted 2025-05-16 · Open, Classified

Recall details

Recalling firm

Echopixel, Inc.

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.

Action taken

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 awareness for a three-month period. d)If devices were transferred to other departments or organizations, provide a copy of this notice to these consignees. Firm will contact customers to provide information about the timing and delivery mechanisms of the software upgrade. If you have questions, contact the firm at: 1-844-273-7766 x2

Root cause

Device Design

Status

Open, Classified

Product code

LLZ

Quantity affected

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.

Date initiated

2018-02-21

Date posted

2025-05-16

Location

San Jose, CA

Related 510(k) clearances