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.
FDA Recall Z-1974-2010 · Posted 2010-07-09
Recalling FirmMcKesson Provider Technologies - Medical Imaging Group
Recall StatusTerminated
Product CodeDQK
Date Initiated2010-04-15
Date Terminated2010-07-21
Product Quantity26 units; 19 in operational use, 8 as emergency replacement units.
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.
Firm 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.
Root Cause
Software change control
Distribution Pattern
Nationwide distribution: CA, CO, MD, NH, NT, NY, TN, and TX .
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.