Company: Philips Ultrasound Inc.
Date of Enforcement Report: 9/29/2021
Class II
PRODUCT
Affiniti Diagnostic Ultrasound Systems:
Software Versions: 5.0, 5.0.1 and 5.0.2
Models: Affiniti 30 795121, Affiniti 30 795218, Affiniti 50 795208, Affiniti 50 795118, Affiniti 70 795210, Affiniti 70 795119
Recall Number: Z-2484-2021
REASON
Due to a software defect that can intermittently cause the system to lock-up when 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