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

Latest News!

Updated Risk Management training course now available.  Includes:

  • Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
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  • How to perform software hazards analysis.
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