FDA Recall: Software Issue with Ultrasound Reporting

Company: Digisonics, Inc
Date of Enforcement Report: 07/20/2023
Class II

PRODUCT

Digisonics OBView Versions 4.8.2 SP6 – 4.8.3, Ultrasound reporting software

Recall Number:

Z-2214-2023

REASON:

Software issue

RECALLING FIRM/MANUFACTURER:

Digisonics, Inc

VOLUME OF PRODUCT IN COMMERCE:

32 units

DISTRIBUTION:

US Distribution: AK, NH, WY, TX, NE, CA, MD, TX, OR IA, IL, MO, OR, NY, UT, PA, MA, GA, VA, WA, WI, and Internationally to :Aruba

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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