Ultrasound Systems Recalled for Loose Power Connections Causing Thermal Hazard
B-K Medical A/S is recalling 1,648 ultrasound systems due to loose power connections that can cause excessive heat and potential thermal events.
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: This is an FDA Class II recall for a risk-of-harm medical device with potential for thermal hazards. No illnesses, injuries, or deaths have been reported, meeting the criterion for Level 3 (High) severity.
Plain-English summary
B-K Medical A/S is recalling 1,648 ultrasound systems globally, including four models: the bk3000 (model 2300-11), bk3500 (model 2300-41), bk5000 (model 2300-61), and bkActive 2300 (model 2300-66), all with battery options.
The internal power connections at the power inlet of these devices can come loose. This condition can result in excessive heat buildup, which may lead to a thermal event or cause the device to become inoperable.
These devices have been distributed throughout the United States and to countries worldwide, including Australia, Canada, Japan, and many others. Government and military installations also received affected units.
Owners and operators of these devices should contact B-K Medical A/S regarding remediation. If you own or operate one of these ultrasound systems, do not use it if you suspect loose power connections or notice excessive heat during operation.
The recalled product
- Product
- bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
- Manufacturer
- B-K Medical A/S
- Hazard
- thermal-event
- electrical-hazard
- device-failure
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 serial numbers
- GTIN 05704916000264.
Distribution
Distributed nationwide across the United States.
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