Events

Recall of Device Recall Solar

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by General Electric Medical Systems Information Technology.

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
    27558
  • Event Risk Class
    Class 2
  • Event Number
    Z-0092-04
  • Event Initiated Date
    2002-06-14
  • Event Date Posted
    2003-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30066
  • 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
    Detector And Alarm, Arrhythmia - Product Code DSI
  • Reason
    Various user settings may change without an audible warning or visual indication. examples of settings that may change are pacemaker detection which may turn from on to off, selected ecg leads for display, and selected gain settings for a selected waveform.
  • Action
    A 'Patient Safety Alert' letter dated June 14, 2002 was sent to the consignees. The letter recommended certain actions to avoid the problems and stated that the firm''s field service team would contact the consignees to schedule a software revision to eliminate the problem.

Device

Device Recall Solar
  • Model / Serial
    All devices with Solar 8000M software versions 3A, 3B or 3C are affected
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The devices were distributed nationwide in the United States and worldwide.
  • Product Description
    Solar 8000M Patient Monitor with software versions 3A, 3B and 3C
  • Manufacturer
    General Electric Medical Systems Information Technology

Manufacturer

General Electric Medical Systems Information Technology
  • Manufacturer Address
    General Electric Medical Systems Information Technology, 8200 W Tower Ave, Milwaukee WI 53223-3219
  • Source
    USFDA