Philips Lumify Diagnostic Ultrasound — Class II medical device recall Z-0596-2016
Terminated recall by Philips Ultrasound, Inc., reported 2016-01-13, distributed in CA, CT, ND, NV, OR, RI, TN, WA. Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow direction does no
| Recall number | Z-0596-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Ultrasound, Inc., Bothell, WA, United States |
| Recall initiated | 2015-12-09 |
| Classified | 2016-01-06 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2016-08-08 |
| Distributed | CA, CT, ND, NV, OR, RI, TN, WA |
| Quantity | 21 units |
| Serial numbers | USD15L0177, USD15L0178, USD15L0179, USD15L0297, USD15L0298, USN15L0789, USN15L0862, USN15L0863, USN15L0864, USN15L0865, USN15L0866, USN15L0867, USN15L0917, USN15L0918, USN15L0988, USO15L0563, USO15L0564, USO15L0565, USO15L0566, USO15L1087, USO15L1088 |
| Model numbers | 795216, 989605449841 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0596-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.