Recall Z-0596-2016— Philips Ultrasound, Inc.
Class II · Terminated
Class II FDA medical device recall by Philips Ultrasound, Inc., initiated 2015-12-09, terminated 2016-08-08. It names one FDA 510(k) clearance: K152899. Product: Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0). 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
- Philips Ultrasound, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-09
- Terminated
- 2016-08-08
- Firm location
- Bothell, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.