Events

Recall of Device Recall OptimaXR220amx

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
    70924
  • Event Risk Class
    Class 2
  • Event Number
    Z-1407-2015
  • Event Initiated Date
    2014-12-19
  • Event Date Posted
    2015-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135537
  • 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
    An issue was identified with the mas accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
  • Action
    GE Healthcare planned action: 1. The customer notification letter will be distributed to the facilities that have installed the following AMX series X-ray systems: Models Brivo XR285 AMX, Optima XR200 AMX, and Optima XR220 AMX. 2. As stated in the customer notification letter, the correction will be provided free of charge and subsequent communication between the firm and the facility will result in a site visit by a GE Healthcare field engineer to bring the X-ray system into compliance. 3. The GEHC field engineer will follow Field Modification Instruction 10899 which provides instructions on how to perform a mAs accuracy check and how to determine if the test results pass predetermined acceptance criteria. If you have any questions or concerns regarding this notification, please call the Information following phone number: 1-800-437-1171.

Device

Device Recall OptimaXR220amx
  • Model / Serial
    OptimaXR220amx PN 5555000-5, PN5555000-6
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of: AZ, FL, GA, MO and WI.
  • Product Description
    GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Manufacturer Address
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA