20

Jan

2021

Recall – Certain ultrasound system workflows result in incorrect patient data

recall, softwareerror

0

Company: Philips Ultrasound Inc
Date of Enforcement Report: 1/20/2021
Class II

PRODUCT

All EPIQ and Affiniti Ultrasound systems. Model numbers – EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD – EPIQ 5 GMDN – 40761 100-240V 50/60 Hz, 600 VA MOD – EPIQ 7 GMDN – 40761 100-240V 50/60 Hz, 600 VA MOD – EPIQ 100-240V 50/60 Hz, 600 VA MOD – Affinity 30 GMDN – 40761 100-240V 50/60 Hz, 450 VA MOD – Affinity 50 GMDN – 40761 100-240V 50/60 Hz, 450 VA MOD – Affinity 70 GMDN – 40761 100-240V 50/60 Hz, 450 VA.

Recall Number: Z-0864-2021

REASON

The manufacturer has determined that with certain uncommon workflows there is potential for incorrect patient data to be displayed and saved into an exam. The issue(s) manifest differently for different versions of software.

RECALLING FIRM/MANUFACTURER

Philips Ultrasound Inc. on 10/27/2020. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

57,430 units

DISTRIBUTION

U.S. Nationwide and International

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