# FDA recall Z-2214-2023

> **Digisonics, Inc** · Class II · device recall initiated 2023-06-26.

## 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

- **Recall number:** Z-2214-2023
- **Recalling firm:** Digisonics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-26
- **Report date:** 2023-07-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Raleigh, NC, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-2214-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2214-2023. Source: US FDA. Licensed CC0.

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