Events

Recall of Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner

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
    55555
  • Event Risk Class
    Class 2
  • Event Number
    Z-1616-2010
  • Event Initiated Date
    2010-04-19
  • Event Date Posted
    2010-05-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91133
  • 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
    Magnetic Resonance Specialty Coil - Product Code MOS
  • Reason
    Hitachi determined that the mounting method for a compensation coil did not include an appropriate factor of safety, so it is possible that the coil could fall, contacting the patient table and potentially putting a patient at risk.
  • Action
    On 4/15/2010 the firm sent Device Correction Notice letters to their customers identifying the affected product and informing them of the potential problem. The letter stated that the firm will change the coil mounting method used at the customer's facility, if necessary, at no cost to the customer. A service rep will contact them to schedule a visit to correct the problem.

Device

Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner
  • Model / Serial
    Part numbers: MR-FC-2EO, MR-FC-3EO
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- AL, AR, AZ, CA, CT, DC, DE, FL, ID, IL, IN, KY, LA, MD, MO, NJ, NY, OH, OK, OR, RI, TN, TX, VA & WA.
  • Product Description
    Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO
  • 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
  • Manufacturer Parent Company (2017)
    Hitachi Ltd
  • Source
    USFDA