Digisonics OBView Versions 4 — Class II medical device recall Z-2214-2023
Ongoing recall by Digisonics, Inc, reported 2023-07-26, distributed in AK, CA, GA, IA, IL, MA, MD, MO…. Software issue
| Recall number | Z-2214-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Digisonics, Inc, Raleigh, NC, United States |
| Recall initiated | 2023-06-26 |
| Classified | 2023-07-20 |
| Reported by FDA | 2023-07-26 |
| Distributed | AK, CA, GA, IA, IL, MA, MD, MO, NE, NH, NY, OR, PA, TX, UT, VA, WA, WI, WY |
| Countries outside the US | AW |
| Quantity | 32 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00857050006014 |
Product
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Reason for recall
Software issue
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2214-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.