Brand
B-K Medical A/S
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for B-K Medical A/S and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-10-30FDA-DeviceClass IIbk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inoperable.
- 2024-01-31FDA-DeviceClass IIbkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
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