Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
This recall is currently active, issued July 20, 2023. It was issued by Digisonics, Inc.
- Company
- Digisonics, Inc
- Recall Initiated
- June 26, 2023
- Posted
- July 20, 2023
- Recall Number
- Z-2214-2023
- Quantity
- 32 units
- Firm Location
- Raleigh, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Software issue
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
Lot / Code Info
UDI?DI 00857050006014, Versions 4.8.2 SP6 - 4.8.3
Root Cause
Labeling design
Action Taken
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.