Events

Recall of Macan Model MC4A Dental Electrosurgical Unit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Macan Engineering and Manufacturing Co., 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
    34948
  • Event Risk Class
    Class 2
  • Event Number
    Z-0810-06
  • Event Initiated Date
    2006-04-05
  • Event Date Posted
    2006-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44988
  • 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
    Unit, Electrosurgical, And Accessories, Dental - Product Code EKZ
  • Reason
    The product label fails to warn users to use the device on patients with shielded pacemakers only.
  • Action
    Product recall letters dated 4/5/06 were sent to the distributors, along with recall packages dated 3/23/06, to be sent out to their customers who purchased a MC-4A instrument. The recall packages consist of a customer letter dated 3/23/06, a new warning label - part number 4ALB-001, installation instructions for the label placement, a customer response sheet, and a self-addressed stamped return envelope for the response sheet. The customer letter informs the customers that the old device label lacked adequate information regarding the use of the instrument on patients with pacemakers, and requesting that they place the enclosed label with the required warnings on the device, and complete and return the response sheet.

Device

Macan Model MC4A Dental Electrosurgical Unit
  • Model / Serial
    Model MC-4A, serial numbers 7001 to 7456
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    Macan Model MC-4A Dental Electrosurgical Unit; Macan Engineering and Manufacturing Co., 1564 N. Damen Avenue., Chicago, Ill 60622 USA (773) 772-2000
  • Manufacturer
    Macan Engineering and Manufacturing Co., Inc.

Manufacturer

Macan Engineering and Manufacturing Co., Inc.
  • Manufacturer Address
    Macan Engineering and Manufacturing Co., Inc., 1564 N Damen Ave, Chicago IL 60622-1942
  • Source
    USFDA