The Recall Desk
HighFDA (Devices)·Z-1380-2016·Announced 2016-04-20

Philips EPIQ Ultrasound Systems Recalled for Control Panel Fastener Loosening

Philips is recalling EPIQ diagnostic ultrasound systems because fasteners securing the control panel may loosen, potentially causing the assembly to detach.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the control panel could detach, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Philips Ultrasound, Inc. is recalling specific models of the EPIQ Diagnostic Ultrasound System, including the EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. The recall involves 11,085 units total, with 4,909 units distributed in the United States and 6,176 units distributed outside the United States.

The recall is due to a defect where the fasteners securing the control panel assembly to the base of the ultrasound system may loosen over time. This loosening could lead to the detachment of the entire control panel assembly from the ultrasound system.

The affected units were distributed worldwide, including in the United States (nationwide, including Washington, D.C.) and numerous countries across the globe. Users of these systems should contact Philips Ultrasound, Inc. for instructions on how to address the issue.

The recalled product

Product
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for ultrasound imaging in abdominal, cardiac adult, cardiac other (fetal), cardiac pediatric, cerebral vascular, cephalic (adult), cephalic (neonata

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Serial numbers

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically: