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 - Medical Imaging Group.

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
    55597
  • Event Risk Class
    Class 2
  • Event Number
    Z-1899-2010
  • Event Initiated Date
    2010-01-27
  • Event Date Posted
    2010-06-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-06-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91248
  • 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
    computer, diagnostic, programmable - Product Code DQK
  • Reason
    Mckesson has identified a potential hardware configuration problem in some horizon cardiology hemo systems which may cause delay and/or loss of the patient's physiological parameters on the horizon cardiology hemo screen and on the patient record.
  • Action
    The firm, McKesson Israel Ltd., sent notification letter dated January 27, 2010 to customers. The letter describes the product, problem and action to be taken by customers and the firm. McKesson's will be contacting the customer to coordinate replacement of the sound component of the Horizon Cardiology Hemo system and will provide the additional sound adapter for all affected systems at your facility at not cost. The customers were instructed to pleasel immediately conduct the following instructions to disable sound operations-1) Open McKesson Management Console and locate the Windsurfer>Monitor Settings; 2) Uncheck "Enable QRS beep" in the sounds section; 3) Locate Windsufer>Hardware Settings in McKesson Management Console, and 4) Uncheck "Enable QRS beep" in the Analog Output, QRS Beep Section. If you have any questions, please do not hesitate to contact Ronen Gans directly at (973) 355-9900.

Device

Device Recall Horizon Cardiology Hemo Monitoring System
  • Model / Serial
    Serial numbers: 2008052847, 2008072107, 2008092609, 2008092608, 2009010800, 2008121714, 2008101609, 2008101608, 2008101618, 2008110391, 2008110390, 2008110389, 2009020226, 2009020227, 2009030603, 2009030602, 2009030601, 2009110399, 2008110398, 2008051520, 2008051519, 2008051518.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: CA, CT, FL, LA, NC, TN, WA, and WV.
  • Product Description
    Horizon Cardiology Hemo Monitoring System || A programmable diagnostic computer intended for acquiring digitizing, storing, displaying , and reviewing hemodynamic data for use in hospital cardiac catherization laboratories.
  • Manufacturer
    McKesson Provider Technologies - Medical Imaging Group

Manufacturer

McKesson Provider Technologies - Medical Imaging Group
  • Manufacturer Address
    McKesson Provider Technologies - Medical Imaging Group, 1639 State Rt 10 Ste 100, Parsippany NJ 07054-4506
  • Manufacturer Parent Company (2017)
    Mckesson Corporation
  • Source
    USFDA