Events

Recall of Device Recall 3T 16ch FlexSPEEDER Coil

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by NeoCoil, 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
    74477
  • Event Risk Class
    Class 2
  • Event Number
    Z-2312-2016
  • Event Initiated Date
    2016-06-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147742
  • 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
    There is a potential for higher than specified surface temperatures involving the 3t 16ch flex speeder large coil.
  • Action
    NeoCoil sent an "Urgent Medical Device Recall" letter dated 17 June 2016. The letter described the problem and the product involved in the recall. Advised consignee to quarantine the product and if the product was further distributed to identify the customers and provide the list to NeoCoil. The recall will be carried to the user level. Requested consignee to complete and return the response form. For questions call 262-522-6127.

Device

Device Recall 3T 16ch FlexSPEEDER Coil
  • Model / Serial
    "Neocoil  serial Number"  046-4-0012 046-4-0013 046-4-0014 046-4-0015 046-4-0016 046-4-0017 046-4-0018 046-4-0019 046-4-0020 046-4-0021 046-4-0022 046-4-0023 046-4-0024 046-4-0025 046-4-0026 046-4-0027 046-4-0028 046-4-0029 046-4-0030 046-4-0031 046-4-0032 046-4-0033 046-4-0034 046-4-0035 046-4-0036 046-4-0037 046-4-0038 046-4-0039 046-4-0040 046-4-0041 046-4-0042 046-4-0043 046-4-0044 046-4-0045 046-4-0046 046-4-0047 046-4-0048 046-4-0049 046-4-0050
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US and Internationally to Georgia, Germany, Korea, Netherlands, Pakistan, Spain, Japan, and the United Kingdom.
  • Product Description
    3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. || To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.
  • Manufacturer
    NeoCoil, LLC

Manufacturer

NeoCoil, LLC
  • Manufacturer Address
    NeoCoil, LLC, N27W23910 Paul Rd Ste A, Pewaukee WI 53072-6204
  • Manufacturer Parent Company (2017)
    Neocoil Llc
  • Source
    USFDA