Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound… recallZ-2214-2023 · Digisonics, Inc · initiated Jun 26, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Digisonics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Software issue

FDA root cause category: Labeling design

What the company is doing

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.

Recall details

Recall number: Z-2214-2023
Status: Open, Classified
Initiated by the company: Jun 26, 2023
Posted by the FDA: Jul 20, 2023
Recalling firm: Digisonics, Inc
Quantity: 32 units
Product code: LLZ
FDA submissions: K970402
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

Product description

Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software

Code information (models, lots, serial numbers)

UDI?DI 00857050006014, Versions 4.8.2 SP6 - 4.8.3

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

OBView 4.8
Digisonics Inc · System, Image Processing, Radiological
1 recall1 report

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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