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B-K Medical A/S recalls bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound sy
Recalled October 30, 2024 · FDA recall Z-0136-2025 · B-K Medical A/S
Hazard
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. · FDA Class II
Units
1648 devices
Sold at
Worldwide - US Nationwide - There was also government/military distribution and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, and United Kingdom.
Description
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.
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(s)
B-K Medical A/S
Made in
Denmark
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →