FDA Medical Device Recalls (openFDA)
B-K Medical A/S: BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN
- Recall number
- Z-2325-2016
- Recalling firm
- B-K Medical A/S
- Product
- BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN
- Status
- Terminated
- Initiated
- 2016-06-28
- Posted
- not on file
- Terminated
- 2016-08-29
- Reason
- In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be unaware of the calculation factor (1) and assume the generic volume calculation factor is similar to that of the other (prostate, adenoma, testis, kidney, and bladder) volume calculation factors provided in the software.
- Root cause
- Software design
- Action
- BK Medical sent an Important Corrective Action Notification letter dated June 27, 2016, to all affected customers. The letter explains the issue and asks customers to discontinue the use of the generic volume measurement and contact BK medical ApS Service for assistance. Customers with questions were instructed to call 800-645-4442.
- Quantity
- 6
- Distribution
- Worldwide Distribution - US to TX, FL, and MA. Internationally to Australia
- Lot, serial or model codes
- Serial Numbers: 5007750, 5008004, 5007734,5007742, 5007596, and50074277
- 510(k) numbers
- ["K140428","K143298","K151910","K152052"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 3003705156
- Firm city
- Herlev
- Firm state
- not on file
- Firm country
- Denmark
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28