Events

Recall of Device Recall BK Medical

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

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
    30410
  • Event Risk Class
    Class 2
  • Event Number
    Z-0271-05
  • Event Initiated Date
    2004-11-12
  • Event Date Posted
    2004-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35818
  • 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
    Defect at probe tip may effect sterilization and electrical safety.
  • Action
    BK Medical Wilmington, MA notified accounts by letter dated 11/ 12 /04 via UPS Overnight.. Accounts are requested to return the unit.

Device

Device Recall BK Medical
  • Model / Serial
    Serial Numbers: 1831984 1831985 1831986 1831987 1831989 1831990 1831992 1832004 1832007 1844219 1844235 1844239 1844240 1844241 1847871 1847875 1847889
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, CO, CT, FL, LA, GA, NJ, NY, VA, VT
  • Product Description
    Linear Array Transducer || Type: 8809
  • Manufacturer
    B & K Medical Systems Inc.

Manufacturer

B & K Medical Systems Inc.
  • Manufacturer Address
    B & K Medical Systems Inc., 267 Boston Rd, North Billerica MA 01862-2310
  • Source
    USFDA