Events

Recall of Device Recall ApexPro FH Telemetry System

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

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
    35826
  • Event Risk Class
    Class 2
  • Event Number
    Z-0054-2007
  • Event Initiated Date
    2006-06-23
  • Event Date Posted
    2006-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46967
  • 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
    Telemetry System - Product Code MHX
  • Reason
    System warning alarm failure: when a patient being monitored is in a pre-existing condition of continuous message or advisory level alarm preceding a system warning level alarm, the system warning audible alarm and flashing yellow border around the patient panel at the cic does not occur.
  • Action
    An Urgent Medical Device Correction letter, dated June 23, 2006, was sent to customers notifying them of the issue, provided short term recommendations and provided the long term solution as a software upgrade that will correct this situation. A reply card is asked to be returned to initiate the upgrade process.

Device

Device Recall ApexPro FH Telemetry System
  • Model / Serial
    Software versions v3.8 and earlier.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution --- including states of AL, AR, AZ, CA, CO, Washington DC, FL, IL, IN, ME, MI, MN, MO, NC, NE, NJ, NY, OK, PA, SC, TX, VA, WA, WI, WV.
  • Product Description
    ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patient worn acquisition transceivers, the patient worn data acquisition transceivers, the transceiver access points with antenna, the network infrastructure, A computer platform running the ApexPro Telemetry Application and a computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application). GE Medical Systems information Technologies, 8200 West Tower Avenue, Milwaukee, WI 53223.
  • Manufacturer
    Ge Healthcare

Manufacturer

Ge Healthcare
  • Manufacturer Address
    Ge Healthcare, 9900 W Innovation Dr, Wauwatosa WI 53226-4856
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA