Events

Recall of Device Recall Prodigy 18 series

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

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
    53692
  • Event Risk Class
    Class 2
  • Event Number
    Z-0601-2010
  • Event Initiated Date
    2009-02-01
  • Event Date Posted
    2010-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86339
  • 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
    Bone Densitometer - Product Code KGI
  • Reason
    Failure to properly pre-indicate the technique factors to be used during a patient scan.
  • Action
    An Important Electronic Product Radiation Warning letter will be sent to customers. The letter will discuss the defect description and related hazards, the affected product details, safety instructions, and product correction. Customers are to contact their local GE Healthcare service representative with questions.

Device

Device Recall Prodigy 18 series
  • Model / Serial
    software versions 12.0, 12.1, 12.2,13.0, & 13.1.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Prodigy 1-8 series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. || The systems provide an estimate of BMD
  • Manufacturer
    Ge Healthcare

Manufacturer

Ge Healthcare
  • Manufacturer Address
    Ge Healthcare, 9900 W Innovation Dr, Wauwatosa WI 53226-4856
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA