FDA recall Z-2214-2023

Product

Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software

Reason for recall

Software issue

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

Key facts

Status

Ongoing

Initiation date

2023-06-26

Report date

2023-07-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Raleigh, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2214-2023