Digisonics, Inc Recall 92619
Description: Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Digisonics, Inc Recall 92619 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2214-2023 |
| Event ID | 92619 |
| Event Description | Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software |
| Product Type | Devices |
| 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 |
| Quantity | 32 units |
| Recall Reason | Software issue |
| Device Classification | 20230726 |
| Device Code Info | UDI?DI 00857050006014, Versions 4.8.2 SP6 - 4.8.3 |
| Center Classification Date | 20230720 |
| Recall Initiation Date | 20230626 |
| Recalling Firm | Digisonics, Inc |
| Initial Notification | |
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