Ultrasound system recalled due to measurement error in Dual Live Compare feature
B-K Medical A/S is recalling bkActiv Ultrasound System 2300 models because a measurement error could occur in the Dual Live Compare feature, potentially affecting diagnostic accuracy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Although this is an FDA Class II recall, no illnesses, injuries, or deaths are reported. The measurement error in a diagnostic ultrasound system represents a risk of harm—incorrect measurements could lead to diagnostic errors—but without reported harm, this falls into the High category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
B-K Medical A/S is recalling the bkActiv Ultrasound System 2300 (Models 2300-56 and 2300-66) due to a potential measurement error in the Dual Live Compare feature. The bkActiv is a medical ultrasound imaging system used for diagnostic purposes.
The Dual Live Compare feature on the affected systems can produce measurement errors, which could impact the accuracy of ultrasound measurements and potentially affect diagnostic interpretation.
The recall affects systems distributed nationwide in the United States, including Alabama, Arizona, California, Florida, Georgia, Idaho, Illinois, Kansas, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia.
Healthcare facilities using the affected systems should contact B-K Medical A/S for information regarding this recall and corrective actions.
The recalled product
- Product
- bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
- Manufacturer
- B-K Medical A/S
- Hazard
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)
- All bkActive (2300-56 and 2300-66) Ultrasound systems
- GTIN 05704916000264.
Distribution
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