Events

Recall of Device Recall Cybernet Medical MedStar Telemedicine System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cybernet Systems Corp..

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
    53785
  • Event Risk Class
    Class 2
  • Event Number
    Z-0853-2010
  • Event Initiated Date
    2008-01-23
  • Event Date Posted
    2010-02-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86511
  • 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
    Transmitters and receivers, electrocardiograph, telephone - Product Code DXH
  • Reason
    A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.
  • Action
    The firm sent out a recall letter dated 10/27/09. Consignees were asked to return the devices in prepaid shipping containers. The recalling firm would do a software upgrade and return the device to the consignee. The firm expects it to take 3-6 months to upgrade all devices. Contact Cybernet Medically immediately, at 1-800-CYBERNET, with the serial number and code versions of the devices in question and Cybernet will start the RMA process for returning the devices for the updates, free of cost.

Device

Device Recall Cybernet Medical MedStar Telemedicine System
  • Model / Serial
    Serial number range affected is 3554 through 3798. Serial numbers 3554, 3559, 5375, 3579, 3584, 3586, 3587, 3594, 3615, 3655, 3664, 3669 ,3670, 3676, 3680, 3682, 3683, 3694, 3696, 3703, 3708, 3725, 3744 and 3798 have not yet been corrected.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: California, Florida, Georgia, Illinois, Louisiana, Michigan, Mississippi, New York, Oklahoma and West Virginia.
  • Product Description
    Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-380. || The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line.
  • Manufacturer
    Cybernet Systems Corp.

Manufacturer

Cybernet Systems Corp.
  • Manufacturer Address
    Cybernet Systems Corp., 727 Airport Blvd, Ann Arbor MI 48108-1639
  • Manufacturer Parent Company (2017)
    Cybernet Systems
  • Source
    USFDA