FDA Device recall Z-0596-2016
Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
- FDA Device
- Class II
- terminated
- Published 2016-01-13
On 2016-01-13 the FDA classified a Class II recall of Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0) by Philips Ultrasound, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0596-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-09 |
| Published | 2016-01-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Ultrasound |
| Distribution | CA, CT, ND, NV, OR, RI, TN, WA |
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.
Identifiers
| code_info | System Serial numbers: USD15L0177; USD15L0178; USD15L0179; USD15L0297; USD15L0298; USN15L0789; USN15L0862; US…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 history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0596-2016%22
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