Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
FDA Recall #Z-2214-2023 — Class II — June 26, 2023
Product Description
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Reason for Recall
Software issue
Recalling Firm
Digisonics, Inc — Raleigh, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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
Code Information
UDI?DI 00857050006014, Versions 4.8.2 SP6 - 4.8.3
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated