Recall – Ultrasound software defect causes system to lock up

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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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USA
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