Home / Recalls / Digisonics, Inc / Z-2214-2023

Z-2214-2023 Class II Ongoing

Recalled by Digisonics, Inc — Raleigh, NC

Recall Details

Product Type
Devices
Report Date
July 26, 2023
Initiation Date
June 26, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32 units

Product Description

Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software

Reason for Recall

Software issue

Distribution Pattern

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