Events

Recall of Device Recall TxRx Knee 15 Coil 3T

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
    62949
  • Event Risk Class
    Class 2
  • Event Number
    Z-2314-2012
  • Event Initiated Date
    2012-07-27
  • Event Date Posted
    2012-09-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112108
  • 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
    On july 27, 2012, it was reported to the firm that the siemens 3t 15ch knee coil was not functional because the coil identification code for the device was incorrect.
  • Action
    Since all of the devices were located at various Siemens distribution locations, all communications were internal to Siemens concerning bringing the coils from one warehouse to another.

Device

Device Recall TxRx Knee 15 Coil 3T
  • Model / Serial
    QED part numbers: Q7000057/QED000057/QSV000057 Siemens part numbers: 10606829 / 10606614  Serial #s: 1002-1012, 1016-1020, and 1022.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide): Tennessee only and country of: Germany
  • Product Description
    TxRx Knee 15 Coil 3T. || For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician.
  • Manufacturer
    Quality Electrodynamics LLC

Manufacturer

Quality Electrodynamics LLC
  • Manufacturer Address
    Quality Electrodynamics LLC, 700 Beta Dr Ste 100, Mayfield Village OH 44143-2378
  • Manufacturer Parent Company (2017)
    Quality Electrodynamics Llc
  • Source
    USFDA