Recall – Ultrasound system intermittently locks-up

Company: Philips Ultrasound Inc.
Date of Enforcement Report: 9/29/2021
Class II

PRODUCT

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

Recall Number: Z-2483-2021

REASON

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

RECALLING FIRM/MANUFACTURER

Philips Ultrasound Inc. on 8/6/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

Total = 10,583 systems (EPIQ and Afiniti)

DISTRIBUTION

U.S. Nationwide and International

Cybersecurity Review

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