Events

Recall of Device Recall Hitachi CXR4 CT (including SceptreP3 PET/CT)

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
    35081
  • Event Risk Class
    Class 2
  • Event Number
    Z-1078-06
  • Event Initiated Date
    2006-02-21
  • Event Date Posted
    2006-06-03
  • 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=45234
  • 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
    Tomography X-ray System - Product Code JAK
  • Reason
    The device has a software anomaly which affects the system's ability to create multiplanar reconstructions (mpr). some images from the resulting series do not display correctly, or display at all, when mpr was run on them.
  • Action
    Hitachi Medical Systems America, Inc. became aware of an intermittent problem in the Multi-planar Reconstruction process when covering long ranges that could result in blank frames in the displayed reconstructions. HMSA also discovered a second software-related problem with the 50mm scale displayed on filmed images. In cases where the image has been magnified before filming, the 50mm scale is not correctly sized to the magnified image. Software corrections have already been installed on all units in order to correct the first of these problems (MPRs). According to the firm''s Device Notification Letter issued on 2/21/2006, a second software upgrade [which the firm states address both issues] will be released on or before 2/27/2006 and this correction will be performed by HMSA''s service personnel during each customer''s next scheduled PM. The Device Notification Letter also instructs the customers to call their Field Service Representatives or the HMSA Applications Helpline if they have any questions about the notice, or if any additional problems are encountered.

Device

Device Recall Hitachi CXR4 CT (including SceptreP3 PET/CT)
  • Model / Serial
    Serial Number: CXR46201-46213 PC 46002-36011
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled MRI systems were distributed throughout the continental United States.
  • Product Description
    Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT)
  • 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