Ultrasound reporting software recalled by manufacturer for software issue
Digisonics has voluntarily recalled OBView ultrasound reporting software versions 4.8.2 SP6 through 4.8.3 due to a software issue. The recall affects 32 units distributed across multiple U.S. states and Aruba.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA recall of ultrasound reporting software with no reported illnesses or injuries. The recall was voluntarily initiated by the manufacturer due to a software issue.
Plain-English summary
Digisonics OBView versions 4.8.2 SP6 through 4.8.3 is ultrasound reporting software. The FDA classified this recall as Class II, affecting 32 units.
Digisonics voluntarily initiated the recall on June 26, 2023, due to a software issue.
The affected software was distributed across the United States to Alaska, New Hampshire, Wyoming, Texas, Nebraska, California, Maryland, Oregon, Iowa, Illinois, Missouri, New York, Utah, Pennsylvania, Massachusetts, Georgia, Virginia, Washington, and Wisconsin. The software was also distributed internationally to Aruba.
The recalled product
- Product
- Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
- Manufacturer
- Digisonics, Inc
- Hazard
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI?DI 00857050006014
- Versions 4.8.2 SP6 - 4.8.3
Distribution
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