Echopixel, Inc.: True 3D Viewer, Model: EP-00003

Is my product affected?

True 3D Viewer, Model: EP-00003

• UPC 00851325007003

Check against the official notice below — it lists the full affected range.

What happened

Echopixel, Inc. is recalling its True 3D Viewer, Model EP-00003, because certain software versions can display ultrasound images with incorrect orientation when imported into the 3D viewer for digital image processing and analysis. This orientation error could result in misdiagnosis or an incorrect surgical treatment plan. Eighteen units were distributed worldwide, including in California, Ohio, New Jersey, Pennsylvania, Massachusetts, Florida, Connecticut, Texas, Louisiana, and Michigan, as well as in Canada.

The affected software versions include full release versions 1.6.1.3080.428 (released April 13, 2017) and 1.6.2.3670.435 (released December 7, 2017), along with multiple development versions for research use released between February 2017 and February 2018. The source document does not specify a remedy or corrective action that consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. 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. Quantity: 18 Lot/code info: UDI-DI: 00851325007003. 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751 Multi-parameter, physiologic patient m2018-02-21
• ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)2018-02-21
• ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-20032018-02-23
• ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-20022018-02-23
• Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament polyester textile. Its intended use is for the repair of abdominal wall hernias or other fascial deficiencies that require the addition of a reinforcing material.2018-02-23

All FDA (Device enforcement) recalls