Events

Recall of Device Recall CXR4CT (including Sceptre P3 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
    35086
  • Event Risk Class
    Class 2
  • Event Number
    Z-1079-06
  • 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=45240
  • 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, X-Ray, Tomography, Computed - Product Code JAK
  • Reason
    The device has a software anomaly which causes blank images to be created during multiplanar reconstruction processing or results in an inherent filming error in which a reference scale is improperly sized.
  • Action
    Hitachi Medical Systems America, Inc. was informed of a software-related problem with the 50mm scale displayed on filmed images. This problem was reported to the firm by their Japanese manufacturer. In cases where the image has been magnified before filming, the 50mm scale is not correctly sized to the magnified image. The firm issued a Device Correctioin Notice to their customers on 2/21/2006. The notice concerns the referenced software problem which results in the resizing of the images, as well as a second previously discovered problem which results in blank multi-planer reconstructions (MPR''s). According to the Device Correction Notice, a software upgrade has already been installed on all of the units in order to correct the MPRs problem [Ref: RES #35081, Correction Removal Report #1528028-01/31/06-003-C] In response to the resizing issue, a second software upgrade [which the firm states address both issues] will be released on or before 2/27/2006, and this software upgrade 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 CXR4CT (including Sceptre P3 PET/CT)
  • Model / Serial
    CXR46201-46214 PC46002-46011
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The 16 devices were distributed to 11 states: Texas, Florida, Louisiana, Illinois, Connecticut, Ohio, Massachusetts, Wisconsin, Idaho, California, New Jersey
  • Product Description
    Hitachi Emission Computed Tomography System || Hitachi CX-4 CT (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