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Recall Observatory FDA recall evidence

Device product

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

Z-0596-2016

December 09, 2015

Class II

Product summary

Firm
Philips Ultrasound, Inc.
Event
Event 72879
Status
Terminated
Classification
Class II
Quantity
21 units in the US only
Official record key
device-enforcement:Z-0596-2016

Official wording

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.