Recall Z-2214-2023— Digisonics, Inc

Name: FDA recall Z-2214-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-26

Class II · Ongoing

Class II FDA medical device recall by Digisonics, Inc, initiated 2023-06-26. It names one FDA 510(k) clearance: K970402. Product: Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software. Reason: Software issue.

Recalling firm: Digisonics, Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-06-26
Firm location: Raleigh, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K970402 — DOCTORS REVIEW SYSTEMDigisonics, Inc.·cleared 1997-03-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software

Reason for recall

Software issue

Data sourced from openFDA. This site is unofficial and independent of the FDA.