Events

Recall of Device Recall Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems

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
    76517
  • Event Risk Class
    Class 2
  • Event Number
    Z-2179-2017
  • Event Initiated Date
    2017-02-06
  • Event Date Posted
    2017-05-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-03-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153410
  • 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
    Table, radiographic, tilting - Product Code IXR
  • Reason
    Reported incidents of a patient step detaching from the table. a fall from a patient step detaching while in use could result in an injury to a patient or operator.
  • Action
    Consignees were sent on 2/6/2017 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# FMI 10908 dated February 3rd, 2017. The letter was addressed to Director of Radiology, Risk Manager/Hospital Administrator & Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact consignee to arrange for the correction.. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

Device Recall Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
  • Model / Serial
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US: Nationwide including DC and Puerto Rico. OUS: Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Egypt, France, Germany, Greece, Honduras, Hungary, Indonesia, Ireland, Israel, Italy, Jamaica, Jordan, Kuwait, Libya, Malaysia, Malta, Mexico, Panama, Portugal, Russia, Saudi Arabia, Saudi Arabia, Slovakia, Spain, Thailand, United Arab Emirates, United Kingdom, Vietnam.
  • Product Description
    Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
  • 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