Events

Recall of Device Recall OEC 9900 Elite

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
    67867
  • Event Risk Class
    Class 2
  • Event Number
    Z-1462-2014
  • Event Initiated Date
    2014-03-31
  • Event Date Posted
    2014-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126531
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Reason
    Ge healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain oec 9900 systems, causing the spring arm and monitor to fall forward.
  • Action
    GE Healthcare sent an Urgent Medical Device Correction letter dated March 31, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Use caution when positioning or extending the workstation articulating arm. In addition, refrain from positioning staff or patients directly underneath or in front of a workstation monitor. Your local GE Healthcare Field Engineer will contact you to coordinate the replacement of the screws, and ensure that your system is operating safely and meets all specifications. These activities will be performed at no cost to you. Should you have any questions or concerns regarding these corrections, please do not hesitate to contact the service team for further information at 800-874-7378 option 8. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately. UPDATE: On June 20, 2014. GE Healthcare Surgery began distributing an Urgent Medical Device Correction Letter to customers with affected units. The letter makes clear that this field correction applies to all user sites with the listed products, regardless of whether service work was performed on the monitor extension arm since 3/31/2014.

Device

Device Recall OEC 9900 Elite
  • Model / Serial
    Model Numbers - OEC 9900 Elite
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, and the countries of Australia, Argentina, Canada, China, Cambodia, Columbia, Japan, Ecuador, Japan, Korea, Hong Kong, India, Israel, Libya, Mexico, Nigeria, Peru, Russia, Thailand, Taiwan, Saudi Arabia and Singapore.
  • Product Description
    The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. || Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretion.
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • Manufacturer Address
    GE OEC Medical Systems, Inc, 384 N Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA