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
    46394
  • Event Risk Class
    Class 2
  • Event Number
    Z-1140-2008
  • Event Initiated Date
    2008-01-24
  • Event Date Posted
    2008-06-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67362
  • 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
    ultrasound transducer - Product Code IYN
  • Reason
    Crack: incomplete glue joint in the device housing may affect electrical safety or sterilization.
  • Action
    B-K Medical issued letter notification on 1/23/08 to accounts via Fed Ex, advising them not to use the unit until a representative can inspect and exchange, if unit is found defective. Instructions are also provided to continue use of the device with a sterile cover until site visit.

Device

Device Recall BK Medical
  • Model / Serial
    Serial Numbers: 1864742, 1869148, 1869619, 1870824, 1870825, 1872061, and 1875317.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Distribution: MA, MI, PA, TX, and OR.
  • Product Description
    B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc., Wilmington, MA 01887
  • Manufacturer
    B & K Medical Systems, Inc.

Manufacturer

B & K Medical Systems, Inc.
  • Manufacturer Address
    B & K Medical Systems, Inc., 250 Andover St, Wilmington MA 01887-1048
  • Source
    USFDA