Events

Recall of Device Recall Horizon Cardiology Hemo Monitoring System

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

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
    46276
  • Event Risk Class
    Class 2
  • Event Number
    Z-0710-2008
  • Event Initiated Date
    2007-11-12
  • Event Date Posted
    2008-02-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67098
  • 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
    Programmable Diagnostic Computer - Product Code DQK
  • Reason
    Power supply reliability: mckesson received word from their manufacturer of the medical grade power supply that some power grade supplies may not provide reliable power output.
  • Action
    Recalled by letter sent to the firm's customers beginning on 11-12-2007, advising them that the field correction would be completed by the recalling firm service technicians.

Device

Device Recall Horizon Cardiology Hemo Monitoring System
  • Model / Serial
    Serial Numbers of subassemblies (ECUs) that contain the affected power supply: A0199, A0200, A0201, A0205, A0208, A0209, A0210, A0225, A0232, A0233, A0234, A0235, and A0236
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide to hospital and medical centers in LA. CA, PA and IL,
  • Product Description
    Horizon Cardiology Hemo Monitoring System;Horizon Cardiology Hemo External Control Unit;~100 - 230 VAC || 50-50 Hz, Medcon Telemedicine Technology LTD.,Tel Aviv, 697190, Israel.
  • Manufacturer
    McKesson Provider Technologies

Manufacturer

McKesson Provider Technologies
  • Manufacturer Address
    McKesson Provider Technologies, 628 State Route 10, Whippany NJ 07981-1522
  • Source
    USFDA