Recall Z-2214-2023 ยท LLZ System, Image Processing, Radiological
Digisonics, Inc
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
| Date | Jul 20, 2023 (initiated Jun 26, 2023) |
| Status | Open, Classified |
| Reason | Software issue |
| Root cause | Labeling design |
| Action | Intelerad/Digisonics issued an "Urgent Medical Device Recall" notice to its consignees by email on 06/26/2023. The notice explained the issue, the hazard, and provided the following information: 1. Digisonics advises all users to pay close attention to the FW% calculation and ensure that it is correct per the actual measurements, which are also displayed within the report. 2. Digisonics will install a warning so that the user is aware that there may be a discrepancy in the FW% displayed. The message will inform of a discordant result, inform the user of what was previously selected and what |
| Quantity | 32 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970402 | DOCTORS REVIEW SYSTEM Digisonics, Inc., Mar 26, 1997 |