Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

EPIQ 7 Ultrasound System with Pediatric Cardiology option Recalled by Philips Ultrasound, Inc. Due to When Epiq 7 Ultrasound System, WITH the Pediatric...

Date: April 10, 2015
Company: Philips Ultrasound, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips Ultrasound, Inc. directly.

Affected Products

EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201. Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1) 453561753631 (1.1.2) 453561772251 (1.2) 453561772631 (1.2.1) 453561786591 (1.2.2) 453561785101 (1.3) 453561800601 (1.3.1) 453561805211 (1.3.2)

Quantity: 2472 units total (1154 units in the US and 1318 outside the US)

Why Was This Recalled?

When Epiq 7 Ultrasound System, WITH the Pediatric Cardiology option, is set up to Metric and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patients Body Surface Area (BSA).

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Philips Ultrasound, Inc.

Philips Ultrasound, Inc. has 17 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report