Philips Ultrasound, Inc. recalls Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software ve…

Recall date

December 9, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0596-2016

FDA classification

Class II

Brand / firm

Philips Ultrasound, Inc.

Sold / distributed

distributed in CA, CT, ND, NV, OR, RI, TN, and WA.

Why it was recalled

Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow direction does not correctly represent the annotated Color Bar or Velocity Markers. (e.g.) When the Color Bar conveys that Red is to be displayed for color flow toward the Transducer, the system displays Blue for color flow toward the Transducer. This could result in misdiagnosis in some studies.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)