Events

Recall of Device Recall Mobile fluoroscopic xray unit.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE OEC Medical Systems, Inc.

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
    38339
  • Event Risk Class
    Class 2
  • Event Number
    Z-0989-2007
  • Event Initiated Date
    2007-07-06
  • Event Date Posted
    2007-07-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53457
  • 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
    fluoroscopic x-ray - Product Code JAA
  • Reason
    The air kerma rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.
  • Action
    Consignees were notified by certified letter on 07/06/2007. They were told that a service rep would contact them to provide a label and an addendum to their operator's manual. A permanent software solution is under development and will be provided when it becomes available.

Device

Device Recall Mobile fluoroscopic xray unit.
  • Model / Serial
    Serial numbers: E2-0083, E2-0096, E2-0100, E2-0122, E2-0139, E2-0141, E2-0144, E2-0153, E2-7040-MH, E2-7054-MH, E2-7062-MH, E2-7070-MH, E9-0012, E9-0029, E9-0059, E9-0085, E9-0106, E9-0114, E9-0170, ES-0052, ES-0159, ES-0171.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, France, Singapore, Sweden, and Switzerland.
  • Product Description
    GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT.
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • Manufacturer Address
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA