Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Summary
The FDA issued a Class II for Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 by Philips Ultrasound, LLC. Reason: Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccura.
Details
Source
Device Recall
External ID
Z-3249-2026
Action Date
2026-09-30
Status
Ongoing
Category
device
Product Description
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Lot/Code Info: All Philips EPIQ Elite Ultrasound Systems running software version 14.0, UDI(s): (01)00884838102514 (01)00884838107540 (01)00884838114159 (01)00884838124912 (01)00884838128125
Quantity Affected: 219 units
Reason for Recall
Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis.
Distribution
Worldwide - US Nationwide distribution in the states of AL, CA, CT, FL, GA, KS, MD, MN, NJ, NY, OH, PA, SC, TN, TX, VA, WA, WI and the countries of Austria, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lithuania, Netherlands, Norway, Philippines, Poland, Romania, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan , United Kingdom, Vietnam.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-07
Company
Bothell, WA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 196 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Philips Ultrasound, LLC has 29 FDA actions in our database, including 3 recalls and 26 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips Ultrasound, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Ultrasound, LLC have FDA actions?
Philips Ultrasound, LLC has 29 FDA actions in our database, including 3 recalls and 26 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3249-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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