FDAClass IIJuly 26, 2023

Digisonics OBView Versions 4.8.2 SP6 - 4.8.3 recall: Software Issue

Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software

Why was Digisonics OBView Versions 4.8.2 SP6 - 4.8.3 recalled?

Software issue

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI?DI 00857050006014, Versions 4.8.2 SP6 - 4.8.3

Product
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Recalling firm
Digisonics, Inc
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
Recall date
July 26, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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