The Recall Desk
ModerateFDA (Devices)·Z-2214-2023·Announced 2023-07-26

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.

What this means for you

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
Category
Medical Device — Ultrasound Reporting Software
Hazard
  • software-defect

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

Distributed in 19 states:

  • AK
  • CA
  • GA
  • IA
  • IL
  • MA
  • MD
  • MO
  • NE
  • NH
  • NY
  • OR
  • PA
  • TX
  • UT
  • VA
  • WA
  • WI
  • WY

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