Events

Recall of Altaire

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
    31768
  • Event Risk Class
    Class 2
  • Event Number
    Z-0797-05
  • Event Initiated Date
    2005-04-11
  • Event Date Posted
    2005-05-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38467
  • 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
    System, Nuclear Magnetic Resonance Imaging - Product Code LNH
  • Reason
    The electrical cables that supply gradient power to the magnet can become loose over time and create a potential fire hazard.
  • Action
    The firm sent a recall/field correction letter, dated 4/11/05, to direct accounts.

Device

Altaire
  • Model / Serial
    Serial numbers: L001 to L212
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Direct accounts located in AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.
  • Product Description
    Altaire, Magnetic Resonance Imaging Device.
  • Manufacturer
    Hitachi Medical Systems America Inc

Manufacturer

Hitachi Medical Systems America Inc
  • Manufacturer Address
    Hitachi Medical Systems America Inc, 1995 Summit Commerce Park, Twinsburg OH 44087-2371
  • Source
    USFDA