Events

Recall of GE Healthcare

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
    63212
  • Event Risk Class
    Class 2
  • Event Number
    Z-0449-2013
  • Event Initiated Date
    2012-08-01
  • Event Date Posted
    2012-11-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113032
  • 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
    System, x-ray, mobile - Product Code IZL
  • Reason
    Ge healthcare has become aware of a software issue on the interface of the mobile radiographic product, optima xr22oamx and optima xr200amx with digital upgrade.
  • Action
    GE Healthcare will without charge remedy the defect or bring the product into compliance with each applicable Federal and IEC standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication through a GE Healthcare field engineer site visit. Field Modification Instructions (FMI) 10868 describes the rework plan the GEHC Engineers will make to the imaging system compliant with the applicable performance standard. This CAP appears to adequately address the problem and is hereby approved. Call Center phone number: 800-437-1171 (United States). For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification.

Device

GE Healthcare
  • Model / Serial
    Model No - 5555000-6
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution
  • Product Description
    GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System || The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, || Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
  • 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