FDA Devices recall · Reported January 13, 2016
Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
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…
Philips Ultrasound, Inc. recalled Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841… - a moderate-severity action.
Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841… was recalled by Philips Ultrasound, Inc. in January 13, 2016. Reason: Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow direction does n…. Check the official notice for the remedy. Verify recall #Z-0596-2016 with the FDA Devices before acting.
The recall
Philips Ultrasound, Inc. issued this moderate-severity FDA Devices recall-Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow direction does n….
- Moderate
- severity level
- 21 units
- affected scope
- Class II
- classification
- January 13, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0596-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0596-2016 |
| Date reported | January 13, 2016 |
| Date initiated | December 9, 2015 |
| Recalling firm | Philips Ultrasound, Inc. |
| Firm location | Bothell, WA |
| Affected scope | 21 units in the US only |
| Distribution | distributed in CA, CT, ND, NV, OR, RI, TN, and WA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0596-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Similar severity · nearest report date
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Methodology · Corrections · Archive as of August 2026