Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound ... (Digisonics, Inc) – software issue (2023)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Brand
Digisonics, Inc
Lot Codes / Batch Numbers
UDI?DI 00857050006014, Versions 4.8.2 SP6 - 4.8.3
Products Sold
UDI?DI 00857050006014, Versions 4.8.2 SP6 - 4.8.3
Digisonics, Inc is recalling Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software due to Software issue. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software issue
Recommended Action
Per FDA guidance
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 it is being changed to, and allow the user to proceed with the changes or revert back. Action Required from Client 1. Advise all users of the Digisonics OBView software of this issue. 2. When the patch update becomes available work with your CSM to have it installed. If you have any questions, call 713-529-7979.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AK, CA, GA, IL, IA, MD, MA, MO, NE, NH, NY, OR, PA, TX, UT, VA, WA, WI, WY
Page updated: Jan 10, 2026