True 3D Viewer, Model: EP-00003

Is this the product you have?

• True 3D Viewer
• ModelEP-00003

Lot codes and dates

• UDI-DI00851325007003
• Full release software versions
  • 1.6.1.3080.428
  • released 13-Apr-2017 1.6.2.3670.435
  • released 07-Dec-2017 Develop Versions
• for research use
  • 0.00.2695.422
  • released 15-Feb-2017 0.00.2927.423
  • released 15-Feb-2017 0.00.2964.423
  • released 24-Feb-2017 0.00.3102.428
  • released 04-Apr-2017 0.00.3245.428
  • released 05-May-2017 0.00.3302.431
  • released 02-Jun-2017 0.00.3344.432
  • released 18-Jul-2017 0.00.3412.433
  • released 14-Aug-2017 0.00.3656.442
  • released 09-Nov-2017 0.00.3669.442
  • released 05-Dec-2017 0.00.3683.445
  • released 02-Jan-2018 0.00.3702.447
  • released 11-Jan-2018 0.00.3730.447
  • released 08-Feb-2018

Amount recalled

18

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

• TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35…

Where it was sold

• Nationwide
• CA
• OH
• NJ
• PA
• MA
• FL
• CT
• TX
• LA
• MI
• MN

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.