Events

Recall of Device Recall Echostar Spica

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alltech Medical Systems America 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
    70238
  • Event Risk Class
    Class 1
  • Event Number
    Z-1061-2015
  • Event Initiated Date
    2015-01-09
  • Event Date Posted
    2015-02-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132616
  • 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 mri system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.
  • Action
    Altech Medical Systems America Inc., notified customers on January 9, 2015, of the problem via telephone. Customers were instructed to immediately cease using the product until the correction can be made. A follow-up letter was sent through the mail, which stated that a service engineer would make a site visit to ramp down the magnet until the issue can be corrected. Customers were asked to complete the attached Acknowledgement and Receipt Form and fax it to (440) 424-2255. For questions contact AMSA at 1-855-200-2672.

Device

Device Recall Echostar Spica
  • Model / Serial
    Serial numbers: D-ESP-1001 and D-ESP-1003
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution in the state of Maryland.
  • Product Description
    Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
  • Manufacturer
    Alltech Medical Systems America Inc

Manufacturer

Alltech Medical Systems America Inc