Events

Recall of 3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by USA Instruments Incorporated.

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
    36612
  • Event Risk Class
    Class 2
  • Event Number
    Z-0164-2007
  • Event Initiated Date
    2006-09-20
  • Event Date Posted
    2006-11-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49150
  • 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
    MRI - Product Code MOS
  • Reason
    The firm determined that certain potential conditions for use of their medical device, outside of recommended practices, or operating manual descriptions, could result in a localized rf burn and/or electrical shock to a patient on which the device is being used.
  • Action
    The user/customers were notified of this recall with an ''Urgent Customer Safety Notification'' which was sent to the user/customers via Certified mail per recall letter dated 09/20/2006. The notification informs the customer(s) of this potential problem and the three (3) conditions under which this problem (patient becoming burned) could possibly occur. The notification goes on to inform the customers that the firm will be upgrading all 1.5T HD Head Neck & Spine Arrays so as to eliminate this potential hazard, at no cost to the customer and that a Service Representative will be contacting the customer in order to make arrangements to upgrade the coil on-site. A toll-free telelphone no. is provided in the notification letter for questions and/or comments. Lastly, the recall notification provides interim instructions which the customer should follow. The operator/technician should: ask that the patients place their hands at their sides during a scan; immediately discontinue the scan if the patient undergoing the scan starts to move; and stay in constant visual and oral contact with the patient undergoing the scan at all times. For the 3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System, The user/customers were notified of this recall with an ''Urgent Customer Safety Notification'' which was sent to the user/customers via Certified mail per recall letter dated 10/13/2006.

Device

3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System
  • Model / Serial
    The following Serial Numbers of this device were subject to recall: 101, 102, 201, 202, 203, 204, 205, 206, 207, 309, 310.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, (states of CA, NJ, PA, MN, IA, MA, WI, WA, and FL) Switzerland, the United Kingdom, France, Canada and Finland.
  • Product Description
    3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System.
  • Manufacturer
    USA Instruments Incorporated

Manufacturer

USA Instruments Incorporated
  • Manufacturer Address
    USA Instruments Incorporated, 1515 Danner Dr, Aurora OH 44202-9273
  • Source
    USFDA