Events

Recall of Device Recall BK Medical ApS Ultrasound System Scanner

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by B-K Medical A/S.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74691
  • Event Risk Class
    Class 2
  • Event Number
    Z-2325-2016
  • Event Initiated Date
    2016-06-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148228
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • 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.
  • 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.

Device

Device Recall BK Medical ApS Ultrasound System Scanner
  • Model / Serial
    Serial Numbers: 5007750, 5008004, 5007734,5007742, 5007596, and50074277
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US to TX, FL, and MA. Internationally to Australia
  • Product Description
    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
  • Manufacturer
    B-K Medical A/S

Manufacturer

B-K Medical A/S
  • Manufacturer Address
    B-K Medical A/S, Mileparken 34, Herlev Denmark
  • Manufacturer Parent Company (2017)
    Bk Medical Holding Aps
  • Source
    USFDA