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