Events

Recall of Device Recall Programmable Stimulator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fischer Imaging Corporation.

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
    30986
  • Event Risk Class
    Class 2
  • Event Number
    Z-0713-05
  • Event Initiated Date
    2005-01-13
  • Event Date Posted
    2005-04-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36935
  • 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
    Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) - Product Code JOQ
  • Reason
    Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients.
  • Action
    Customers were notified by letter on 01/13/05.

Device

Device Recall Programmable Stimulator
  • Model / Serial
    All Bloom DTU-215-B Programmable Stimulators.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Foreign distribution: Canada, Australia, Ireland, Italy, Japan, Malaysia, Switzerland, Netherlands, United Kingdom.
  • Product Description
    Bloom DTU-215-B Programmable Stimulator
  • Manufacturer
    Fischer Imaging Corporation

Manufacturer

Fischer Imaging Corporation
  • Manufacturer Address
    Fischer Imaging Corporation, 12300 Grant St, Denver CO 80241-3120
  • Source
    USFDA