Events

Recall of Hitachi Oasis MRI Coil Extension Cable

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hitachi 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
    71431
  • Event Risk Class
    Class 2
  • Event Number
    Z-2366-2015
  • Event Initiated Date
    2014-04-25
  • Event Date Posted
    2015-08-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137842
  • 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 stating the coil extension cable accessory would overheat and be a burn hazard if touched.
  • Action
    Hitachi sent an Urgent: Device Removal Notice letter date April 24, 2014 to their customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers to discontinue using the Coil Extension Cable and that a Field Service Engineer will schedule a visit to remove the cable. For questions call 800-800-3106 ext 3720.

Device

Hitachi Oasis MRI Coil Extension Cable
  • Model / Serial
    Serial #'s: M001to M108, M110 to M175, M951 & M952.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide in the states: AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI & WY and the country of Mexico.
  • Product Description
    Oasis Coil Extension Cable used with Hitachi Oasis MRI System || Product Usage: || The Oasis MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination. The Coil Extension Cable that is the subject of the removal action is an accessory that is used in conjunction with certain anatomy coils to aid in patient positioning.
  • Manufacturer
    Hitachi Medical Systems America Inc

Manufacturer

Hitachi Medical Systems America Inc
  • Manufacturer Address
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087-2371
  • Manufacturer Parent Company (2017)
    Hitachi Ltd
  • Source
    USFDA