FDA Device recall Z-2214-2023
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
- FDA Device
- Class II
- ongoing
- Published 2023-07-26
On 2023-07-26 the FDA classified a Class II recall of Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software by Digisonics, citing software issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2214-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-26 |
| Published | 2023-07-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Digisonics |
| Distribution | AK, CA, GA, IA, IL, MA, MD, MO, NE, NH, NY, OR, PA, TX, UT, VA, WA, WI, WY |
Product
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Reason
Software issue
Identifiers
| code_info | UDI?DI 00857050006014, Versions 4.8.2 SP6 - 4.8.3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2214-2023%22
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