B-K Medical A/S: Device Recall
Recall #Z-0136-2025 · 09/04/2024
Recall Details
- Recall Number
- Z-0136-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- B-K Medical A/S
- Status
- Ongoing
- Date Initiated
- 09/04/2024
- Location
- Herlev, N/A, Denmark
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1648 devices
Reason for Recall
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 Description
bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
Distribution Pattern
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.
Other Recalls by B-K Medical A/S
- Class II: Risk 10/09/2025
- Class II: Risk 10/09/2025
- Class II: Risk 10/09/2025
- Class II: Risk 10/09/2025
- Class II: Risk 10/09/2025