Recall archive / FDA device enforcement
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software — FDA record Z-2214-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 26, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
- Reason
- Software issue
- Classification
- Class II
- Recalling firm
- Digisonics, Inc
- Quantity
- 32 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2214-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI?DI 00857050006014, Versions 4.8.2 SP6 - 4.8.3 |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 26, 2023
- Recall initiation date
- Jun 26, 2023
- Center classification date
- Jul 20, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.