Z-1974-2010

Horizon Cardiology Hemo Component Schiller Argus Pro PB-1000 Monitor unit. Argus Pro PB 1000 firmware...

Name: Z-1974-2010 Horizon Cardiology Hemo Component Schiller Argus Pro PB-1000 Monitor unit. Argus Pro PB 1000 firmware...
Creator: McKesson Provider Technologies - Medical Imaging Group
Published: 2010-04-15
License: https://open.fda.gov/license/

Change Healthcare Technologies LLC / initiated 2010-04-15 / Terminated / root cause: software

FDA source

McKesson Provider Technologies - Medical Imaging Group began a recall of 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... on 2010-04-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1974-2010
Status: Terminated
Initiated: 2010-04-15
Posted: 2010-07-09
Terminated: 2010-07-21
Recalling firm: Change Healthcare Technologies LLC
Product: 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.
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software change control
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.
Quantity in commerce: 26 units; 19 in operational use, 8 as emergency replacement units.
Distribution: Nationwide distribution: CA, CO, MD, NH, NT, NY, TN, and TX .
Product codes and lots: 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 code DQK

K050561Class IIWindsurferMedcon , Ltd. / cleared 2005-05-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)