Jan

2016

Philips Lumify Diagnostic Ultrasound Cl II

Company: Philips Ultrasound Inc
Date of Enforcement Report 1/13/2016
Class lI:

PRODUCT

Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
Recall Number Z-0596-2016

REASON
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.

RECALLING FIRM/MANUFACTURER
Philips Ultrasound Inc, Bothell WA on 12/9/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
21 units

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

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Philips Lumify Diagnostic Ultrasound Cl II

Amy Sellers

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