Events

Recall of Device Recall EZDOP

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DWL 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
    28472
  • Event Risk Class
    Class 3
  • Event Number
    Z-0885-04
  • Event Initiated Date
    2004-01-05
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31967
  • 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
    A certain sequence of data entries on the keypad could cause the ultrasound medical device to display incorrect transmission power.
  • Action
    The firm notified consignees by mail on 1/5/2004 and advised of potential for inaccurate power display when the device is actually transmitting. Consignees were requested to return the device for a software upgrade.

Device

Device Recall EZDOP
  • Model / Serial
    Serial numbers LDP4 0024 through LDP4 390.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Units were distributed to end users worldwide including 67 domestic consignees.
  • Product Description
    EZ-DOP, diagnostic ultrasound imaging system
  • Manufacturer
    DWL Systems, Inc.

Manufacturer

DWL Systems, Inc.
  • Manufacturer Address
    DWL Systems, Inc., 100 Carpenter Drive, Suite 202, Sterling VA 20164
  • Source
    USFDA