Events

Recall of Horizon Cardiology Hemo Component Schiller Argus Pro PB1000 Monitor unit

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
    55598
  • Event Risk Class
    Class 2
  • Event Number
    Z-1974-2010
  • Event Initiated Date
    2010-04-15
  • Event Date Posted
    2010-07-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91258
  • 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 recently discovered that certain horizon cardiology hemo systems were running specific schiller argus-pro pb 1000 firmware versions that might cause a delay in the display of physiological parameters on the horizon cariology hemo real time monitor screen.
  • Action
    The firm, McKesson, sent an "Advisory Notice" letter dated April 15, 2010, to all customers. The letter describes the problem, products affected, and actions to be taken by customers. The customers were instructed not to use the Emergency Replacement Hemo kit until they receive a replacement Schiller Argus Pro PB-1000 and they have contacted McKesson Support department at 1-866-777-0202. If you have any questions regarding this notice, please call our Customer Support department at 1-0866-777-0202 and ask to speak to your support Manager.

Device

Horizon Cardiology Hemo Component Schiller Argus Pro PB1000 Monitor unit
  • Model / Serial
    Argus Pro PB 1000 firmware versions 2.41+M NIBP and 2.42.01+M Serial numbers prefaced with PB-1000: 765.001471, 760.001566, 760.001793, 760.001882, 760.001920, 760.001934, 760.001970, 760.002043, 760.002113, 765.001168, 765.001307, 765.001520, 765.001553, 765.001599, 765.001609, 765.001510, 765.001632, 765.00165, 765.003014, 760.001320, 760,001552, 760.001555, 760,001920, 760.002107, 765.001224, 765.001306, 765.001608.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: CA, CO, MD, NH, NT, NY, TN, and TX .
  • Product Description
    Horizon Cardiology Hemo Component Schiller Argus Pro PB-1000 Monitor unit. || Argus Pro PB 1000 firmware versions 2.41+M NIBP and 2.42.01+M. || A programmable diagnostic computer intended for acquiring, digitizing, storing, displaying and reviewing hemodynamic data for use in hospital cardiac catheterization laboratories. The system is cleared for us with a component physiological data collection unit - the Schiller Argus Pro PB 1000 Monitor unit.
  • 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