Events

Recall of MACLAB

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by General Electric Medical Systems Information Technology.

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
    25951
  • Event Risk Class
    Class 2
  • Event Number
    Z-0785-03
  • Event Initiated Date
    2003-04-14
  • Event Date Posted
    2003-04-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-06-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26763
  • 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
    Monitor, Bed Patient - Product Code KMI
  • Reason
    There is an incorrect jumper set-up on a motherboard of the devices that could eventually cause a polyfuse to overheat resulting in smoke.
  • Action
    A letter was sent to the consignees on April 14, 2003 and requested that the consignees correct the device or contact the firm to have them perform the correction.

Device

MACLAB

Manufacturer

General Electric Medical Systems Information Technology
  • Manufacturer Address
    General Electric Medical Systems Information Technology, 8200 W. Tower, Milwaukee WI 53223
  • Source
    USFDA