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
    27811
  • Event Risk Class
    Class 2
  • Event Number
    Z-0250-04
  • Event Initiated Date
    2003-11-10
  • Event Date Posted
    2003-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30559
  • 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
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) - Product Code MHX
  • Reason
    Software gives inaccurate readings when transferring tram module from solar 9500 to other solar monitoring systems without discharging tram first.
  • Action
    A letter dated November 10, 2003 was sent to the consignees. The letter recommended certain actions to avoid the problems and provided options for the software to be updated.

Device

Device Recall Solar
  • Model / Serial
    Solar 9500 Information Monitor with software version 3A.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to consignees located nationwide in the United States and worldwide.
  • Product Description
    Solar 9500 Information Monitor with software version 3A.
  • 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