Device product
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Z-2214-2023
Product summary
- Firm
- Digisonics, Inc
- Event
- Event 92619
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 32 units
- Official record key
device-enforcement:Z-2214-2023
Official wording
Reason: Software issue
Code information: UDI?DI 00857050006014, Versions 4.8.2 SP6 - 4.8.3
Distribution pattern: 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
Derived failure modes
-
Device software or design
Software issue