Events

Recall of Device Recall Optima

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
    62946
  • Event Risk Class
    Class 2
  • Event Number
    Z-2255-2012
  • Event Initiated Date
    2012-07-10
  • Event Date Posted
    2012-09-13
  • 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=112106
  • 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
    Software issue: a violation of 21 cfr 1020.31(a). after an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
  • Action
    The firm will issue Important Electronic Product Radiation Warning letters that identify the affected product along with a description of the defect and related hazards. Users are instructed to ensure that the acquisition mode is always selected prior to attempting an exposure to confirm the techniques selected. The firm will remedy the issue or bring the device into compliance free of charge. A GE Healthcare Service Representative will update the software on the system to address the issue. Field Modification Instructions (FMI) 10865(2) describes the rework plan the GEHC Engineers will make to the imaging system to return it to compliance with the applicable performance standard. It appears to adequately address the problem and is hereby approved. Users are to contact 800-437-1171 in the US, if they have any questions or concerns.

Device

Device Recall Optima
  • Model / Serial
    Part Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) Distribution
  • Product Description
    Optima XR200amx. 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