Events

Recall of Digital Radiography System Model DFP8000D

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Toshiba American Med Sys 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
    34091
  • Event Risk Class
    Class 2
  • Event Number
    Z-0324-06
  • Event Initiated Date
    2005-11-10
  • Event Date Posted
    2005-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43102
  • 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, Fluoroscopic, Image-Intensified - Product Code JAA
  • Reason
    To correct a software problem that caused the lv images, which were acquired for 15 seconds at the end of the examination, to be lost.
  • Action
    An Advisory Letter was sent to the customers via certified mail. Toshiba issued a Field Modification Instruction (FMI XRA29-90828) to correct that software bug and bring the DFP-8000D into compliance. The FMI is provided to the customers at no charge.

Device

Digital Radiography System Model DFP8000D
  • Model / Serial
    Serial Numbers: A3622068 A4512074 A3582042 A3542012 A4512073 A3552017 A4552098 A3622065  A3622066 A4542090 A3592048 B4602125 B4612134 B5512155 B4582116 W1B0542168 A3572018 A4562102 A35B2041 B4612132 A3542011 A3582037 A3622069 B4622149 B4602129 A3542006 B4612133 A3572032 A3522002 B4622146 A3542008 A3602050 A4512076 A4522079 A4522081  B4622150 B5522162 A3592046 A3532005 A3612057 A4572109 A3517002 B4622148 A4562099 A3612061 A4562101 B4612137 A3602055 A4542092 B5512154 A4542088 A3572030 A3582035 A3522004 A3562022 A3582036 B4622151 A3582013 A3582013 A45721 07 B4612141 A3517003 A4522080 A3522001 W180542173
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Digital Radiography System Model DFP8000D
  • Manufacturer
    Toshiba American Med Sys Inc

Manufacturer

Toshiba American Med Sys Inc
  • Manufacturer Address
    Toshiba American Med Sys Inc, 2441 Michelle Dr, Tustin CA 92781
  • Source
    USFDA