Reported Jan 13, 2016 · Terminated
Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software…
Philips Ultrasound, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Ultrasound, Inc. · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431
Is this the product you have?
- Philips Lumify Diagnostic Ultrasound
- Catalogue Number795216
- Part Number989605449841 with 453561845331 (software version 1.0)
- Lot codes and dates
21 of 21 products
Products covered by this recall # Product as published 1 USD15L0177 2 USD15L0178 3 USD15L0179 4 USD15L0297 5 USD15L0298 6 USN15L0789 7 USN15L0862 8 USN15L0863 9 USN15L0864 10 USN15L0865 11 USN15L0866 12 USN15L0867 13 USN15L0917 14 USN15L0918 15 USN15L0988 16 USO15L0563 17 USO15L0564 18 USO15L0565 19 USO15L0566 20 USO15L1087 - Amount recalled
- 21 units in the US only
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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