FDA-Device2016-01-13Class II
Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
Philips Ultrasound, Inc.
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.
Sold states
distributed in CA, CT, ND, NV, OR, RI, TN, and WA.
Affected count
21 units in the US only
Manufactured in
22100 Bothell Everett Hwy, N/A, Bothell, WA, United States
Products
Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0596-2016Don't want to check this manually?
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