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Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 45...

FDA Recall #Z-0596-2016 — Class II — December 9, 2015

Recall #Z-0596-2016 Date: December 9, 2015 Classification: Class II Status: Terminated

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.

Recalling Firm

Philips Ultrasound, Inc. — Bothell, WA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

21 units in the US only

Distribution

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

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.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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