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
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