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 Diagnostic Ultrasound Systems: Software Versions 5.0 Recalled by Philips Ultrasound Inc Due to Due to a software defect that can intermittently...

Date: August 6, 2021
Company: Philips Ultrasound Inc
Status: Completed
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 Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231

Quantity: Total = 10,583 systems (EPIQ and Afiniti)

Why Was This Recalled?

Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.

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 14 total recalls tracked by RecallDetector.

Related Recalls

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