Events

Recall of Mobile X Ray Series

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
    63597
  • Event Risk Class
    Class 2
  • Event Number
    Z-0197-2013
  • Event Initiated Date
    2012-09-20
  • Event Date Posted
    2012-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114301
  • 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
    Image-intensified fluoroscopic x-ray system mobile - Product Code OXO
  • Reason
    It was discovered ge healthcare has become aware of a firmware issue on the mobile radiographic product, brivo xr285amx, optima xr200amx, optima xr22oamx and optima xr200amx with digital upgrade, related to technique accuracy as mandated by the us code of federal regulations (21cfr) and iec 60601-2-54.
  • Action
    GE Healthcare will remedy the defect or bring the product into compliance with each applicable Federal and IEC standard. A Service Representative will update the firmware on the system to address the issue. Field Modification Instructions (FMI) 10870, 10872, and 10873 are describing the rework plan the GEHC Engineers will make to the imaging systems compliant with the applicable performance standard. Further questions please call (262) 513-4122.

Device

Mobile X Ray Series
  • Model / Serial
    part number: 5421698
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    GE Healthcare Optima XR 200amx with digital upgrade || Mobile general purpose radiographic imaging of the human head and body.
  • 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