Philips Ultrasound, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0596-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)

Product Classification:

Class II

Date Initiated: December 9, 2015

Date Posted: January 13, 2016

Recall Number: Z-0596-2016

Event ID: 72879

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.

Status: Terminated

Product Quantity: 21 units in the US only

Code Information:

System Serial numbers: USD15L0177; USD15L0178; USD15L0179; USD15L0297; USD15L0298; USN15L0789; USN15L0862; USN15L0863; USN15L0864; USN15L0865; USN15L0866; USN15L0867; USN15L0917; USN15L0918; USN15L0988; USO15L0563; USO15L0564; USO15L0565; USO15L0566; USO15L1087; and USO15L1088.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated