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Medical device recall · FDA · Published August 7, 2026

Philips Ultrasound, LLC recalls Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234

Philips recalls EPIQ Elite ultrasound systems with software version 14.0 due to potential inaccurate blood flow velocity measurements, risking misdiagnosis. Affected units include specific model numbers and UDI codes.

🇺🇸 FDA recall #Z-3249-2026Medical devicePhilips ›
✎ GovInfoNow plain-language explainer

What happened, in plain English

Philips is recalling EPIQ Elite ultrasound systems with software version 14.0 because a software issue causes blood flow measurements to be displayed incorrectly. This could lead to misdiagnosis if the ultrasound is used for medical assessments. Read more at govinfonow.com/recall/1292646-philips-epiq-elite-ultrasound-system-recall-inaccurate-blood-flow-measurements.

Source Summary by GovInfoNow · govinfonow.com/recall/1292646-philips-epiq-elite-ultrasound-system-recall-inaccurate-blood-flow-measurements · Published October 6, 2026 · Updated October 6, 2026 · FDA enforcement record: FDA #Z-3249-2026

Cite this page

“Philips EPIQ Elite Ultrasound System Recall: Inaccurate Blood Flow Measurements.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/1292646-philips-epiq-elite-ultrasound-system-recall-inaccurate-blood-flow-measurements. Based on FDA recall #Z-3249-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3249-2026%22&limit=1).

Why it’s dangerous

The software issue causes the ultrasound system to display blood flow measurements at a shallower depth than actual. This can lead to inaccurate blood flow velocity readings, potentially causing misdiagnosis during medical assessments.

Who’s affected

Healthcare professionals using Philips EPIQ Elite ultrasound systems with software version 14.0 are most at risk. Patients receiving ultrasounds from these systems may also be affected if misdiagnosis occurs.

How to tell if you have this one

Check for model number 795234 or software version 14.0. Affected units have specific UDI codes: (01)00884838102514, (01)00884838107540, (01)00884838114159, (01)00884838124912, (01)00884838128125.

  • Brand
    Philips
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify the software version on your EPIQ Elite ultrasound system; affected units run version 14.0.

✎ GovInfoNow

Questions people ask

Why is this ultrasound system being recalled?

The recall is due to a software issue that causes blood flow measurements to be displayed incorrectly, which could lead to misdiagnosis.

What should I do if I have this ultrasound system?

Check your software version; if it's 14.0, contact Philips for guidance on next steps.

How can I tell if my system is affected?

Affected units have model number 795234 or software version 14.0 with specific UDI codes listed in the recall notice.

Take action

Contact Philips

We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.

Subject: Recall Z-3249-2026 — Philips Philips

Hello,

I own a Philips that is covered by recall Z-3249-2026 from Philips.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-3249-2026 (August 7, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3249-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA