Echopixel, Inc.: TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the

Is my product affected?

TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D Viewer (t3D-Viewer) system is

• UPC 00851325007003

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

What happened

Echopixel, Inc. has recalled 9 TRUE 3D VIEWER SYSTEM devices (Model Number EP-00001-XX) with software versions 1.0, 1.25, and 1.35 due to a defect that may cause imaging system data to display with incorrect orientation. Specifically, the patient side information (left, right, superior, inferior, anterior, or posterior) may not be correct, which could lead to inaccurate measurements. The affected systems were distributed worldwide and within the United States in California, Ohio, New Jersey, Pennsylvania, Massachusetts, and Florida, as well as in Canada.

The recall affects nine specific systems identified by their serial numbers. The source document does not specify what steps an affected consumer should take in response to this recall.

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

Hazard

Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements.

Details from the source

Reason for recall: Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements. Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL and the country of Canada. Quantity: 9 systems Lot/code info: Model Number EP-00001-XX with software versions 1.0, 1.25, and 1.35 UDI-DI Codes: 00851325007003 Serial Numbers: Field Products: C2015-09-0001 C2015-09-0003 D2015-05-0002 C2015-06-0002 D2015-12-0004 C2015-08-0001 D2015-12-0005 C2015-09-0002 D2015-12-0001 C2016-01-0001 D2015-12-0002 C2015-12-0002 D2015-12-0003 D2016-01-0002

Source

Official record: FDA (Device enforcement) ↗

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

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