Events

Recall of Device Recall Esaote GScan Brio

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Esaote S.p.A..

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
    74391
  • Event Risk Class
    Class 2
  • Event Number
    Z-2124-2016
  • Event Initiated Date
    2016-06-06
  • Event Date Posted
    2016-07-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147902
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • Reason
    The device is being recalled because dynamic loading forces from larger patients can fracture the extremity portion of the patient table. additionally, a weight limit is added to the patient seat for weight-bearing examinations.
  • Action
    Esaote initiated a voluntary recall of the G-scan Brio Magnetic Resonance System on 06/06/2016 with letters sent via certified, due to a potential weakness on the extremity areas of the patient table that could lead to a stress fracture of the table. The firm has instructed customers to refer to the Medical Device Safety Notification provided with the recall notice, date and sign this letter in the space provided on the last page and send it back via email to quality@esaoteusa.com. If customers have questions regarding the recall, please call 1-317-813-6030. For additional information, please contact us by phone during normal business hours, Monday-Friday from 8:00am  5:00pm Eastern Standard Time, via email at quality@esaoteusa.com, or at any time by visiting our website. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm, by regular mail using the postage-paid, pre-addressed Form FDA3500 available at www.fda.gov/MedWatchgetforms.htm or by fax to 1-800-FDA-0178.

Device

Device Recall Esaote GScan Brio
  • Model / Serial
    Item No., Unit Description and Serial No.s: 101002000, UNIT, G-SCAN BRIO, 05202; 101002000, UNIT, G-SCAN BRIO, 05203; 101002000, UNIT, G-SCAN BRIO 2.1A; 05205; 101002000, UNIT, G-SCAN BRIO 2.1A, 05207; 101002000 UNIT, G-SCAN BRIO 2.1A, 05208; 101002000 UNIT, G-SCAN BRIO 2.1A, 05209; 101002000 UNIT, G-SCAN BRIO 2.1A, 05210; 101002000 UNIT, G-SCAN BRIO 2.1A, 05211; 101002000 UNIT, G-SCAN BRIO 2.1A, 05305; 101002000 UNIT, G-SCAN BRIO 2.1A, 05308
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic: FL, TX, OH, MN, NV; Foreign: No customers in Canada; No VA/DOD.
  • Product Description
    Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
  • Manufacturer
    Esaote S.p.A.

Manufacturer

Esaote S.p.A.