Events

Recall of Device Recall GE eXplore Locus Micro CT.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, LLC.

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
    57842
  • Event Risk Class
    Class 2
  • Event Number
    Z-0833-2012
  • Event Initiated Date
    2011-01-31
  • Event Date Posted
    2012-02-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97538
  • 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
    Cabinet x-ray, industrial - Product Code RCE
  • Reason
    Product fails to comply with the federal performance standard for cabinet x-ray systems (title 21 cfr 1020.40(c)(1)(i)). specifically, the x-ray emission limit of 0.5 milliroentgen in one hour could be exceed. highest emission measured was 3 mr/hr.
  • Action
    GE Healthcare will notify purchasers of the problem, the affected product, instructions for users, and specify the maximum emission rate measured. GE Healthcare will bring defective systems into compliance free of charge. This will be done via Field Modification Instructions IFMI) 11101 which is scheduled for deployment on March 1, 2011 with an estimated completion date of July 1, 2011.

Device

Device Recall GE eXplore Locus Micro CT.
  • Model / Serial
    Part Number 5134163.
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    GE eXplore Locus Micro CT cabinet x-ray system model RS9-80. || CT Scanner for laboratory mice or other research.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA