Digisonics, Inc: Medical Device Recall in 2023 - (Recall #: Z-2214-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software

Product Classification:

Class II

Date Initiated: June 26, 2023

Date Posted: July 26, 2023

Recall Number: Z-2214-2023

Event ID: 92619

Reason for Recall:

Software issue

Status: Ongoing

Product Quantity: 32 units

Code Information:

UDI?DI 00857050006014, Versions 4.8.2 SP6 - 4.8.3

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

Voluntary or Mandated:

Voluntary: Firm initiated