Events

Recall of Device Recall Mirror assembly to 1.5T Atlas SPEEDER HeadNeck Coil

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Quality Electrodynamics Llc.

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
    51281
  • Event Risk Class
    Class 2
  • Event Number
    Z-1938-2009
  • Event Initiated Date
    2008-12-29
  • Event Date Posted
    2009-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79580
  • 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
    Coil, magnetic resonance, specialty - Product Code MOS
  • Reason
    The firm received a complaint indicating that the mirror is high risk and could drop on a patient.
  • Action
    Quality Electrodynamics, LLC notified Customers via email beginning December 29, 2008 requesting the affected device be returned to the firm for improvement. For further information, contact Quality Electrodynamics, LLC at 1-440-484-2228.

Device

Device Recall Mirror assembly to 1.5T Atlas SPEEDER HeadNeck Coil
  • Model / Serial
    Part Number: Q7000021; Serial Number: 070810, 070811, 100804, 100805, and X110810.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: IL and OH.
  • Product Description
    Mirror assembly to magnetic resonance device (1.5T Atlas SPEEDER Head-Neck Coil) Coil Part #Q7000021, Quality Electrodynamics, Mayfield Village, OH 44143. || The indications for use are routine MR imaging.
  • Manufacturer
    Quality Electrodynamics Llc

Manufacturer

Quality Electrodynamics Llc
  • Manufacturer Address
    Quality Electrodynamics Llc, 777 Beta Dr, Cleveland OH 44143-2336
  • Manufacturer Parent Company (2017)
    Quality Electrodynamics Llc
  • Source
    USFDA