Events

Recall of Device Recall Hitachi Altaire Magnetic Resonance Imaging Device

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
    34856
  • Event Risk Class
    Class 2
  • Event Number
    Z-1103-06
  • Event Initiated Date
    2006-01-27
  • Event Date Posted
    2006-06-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44831
  • 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
    MRI Magnetic Resonance Imaging - Product Code LNH
  • Reason
    Circuit failure-there is the potential risk of the phase loss detector safety device (phsen pcb) malfunctioning in the event of a power loss. the circuit may fail to turn off the system main breaker when 2 of the 3 power phases are lost.
  • Action
    The recalling firm sent a Device Correction Letter dated 1/27/06 to all of their customers. The letter informs the customers of the problem in the (PHSEN PCB) and notifies the customers that an HMSA Field Service Technician will be performing a PCB modification to the unit, on-site, during their next scheduled preventative maintenance visit. Should the customer wish to have the modification performed prior to the representative''s scheduled visit, the letter says that they can telephone their local Field Service Rep. and make arrangements to have the modification performed at their convenience.

Device

Device Recall Hitachi Altaire Magnetic Resonance Imaging Device
  • Model / Serial
    L001 thru L223.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide-The device was distributed to consignees located throughout the United States.
  • Product Description
    Hitachi Altaire Magnetic Resonance Imaging System
  • 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