Events

Recall of Device Recall Diagnostic Ultrasound Transducer

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
    34900
  • Event Risk Class
    Class 2
  • Event Number
    Z-0856-06
  • Event Initiated Date
    2006-03-16
  • Event Date Posted
    2006-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44908
  • 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
    Diagnostic Ultrasound Transducer - Product Code IYN
  • Reason
    Due to a problem with calibration, the device can produce up to 50% elevated acoustic output and up to 2 degrees higher surface temperature.
  • Action
    BK Medical notified customers by letter on 4/10/06 via FedEx advising user of the problem and scheduling the software correction by a Service representative visit .

Device

Device Recall Diagnostic Ultrasound Transducer
  • Model / Serial
    Serial Numbers:  1855380, 1855547, 1855548, 1856835, 1856837, 1857171, 1857173, 1857180, 1857427, 1857435, 1857515, 1857748, 1858482, 1858841, 1859751, 1859902, 1860250, 1860262, 1860487, 1860661, 1860858, 1861488, 1861580, 1861581, 1861823, 1861849, 1863084, 1863082
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA,CT, FL, MD, ME, MN, MS, NY, OH, RI, SD, TX, VA
  • Product Description
    Convex Array Transducer used with B-K Ultrasound Scanners || Model number: 8667
  • 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