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Philips Ultrasound, Inc. recalls Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software ve
Recalled January 13, 2016 · FDA recall Z-0596-2016 · Philips Ultrasound
Hazard
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. · FDA Class II
Units
21 units in the US only
Sold at
distributed in CA, CT, ND, NV, OR, RI, TN, and WA.
Description
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.
Product
Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
Manufacturer(s)
Philips Ultrasound, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →