Recall Z-1974-2010 ยท DQK Computer, Diagnostic, Programmable
McKesson Provider Technologies - Medical Imaging Group
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
| Date | Jul 9, 2010 (initiated Apr 15, 2010) |
| Status | Terminated |
| 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. |
| 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 | 26 units; 19 in operational use, 8 as emergency replacement units. |
| Distribution | Nationwide distribution: CA, CO, MD, NH, NT, NY, TN, and TX . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050561 | WINDSURFER Medcon , Ltd., May 4, 2005 |