FDA Medical Device Recalls (openFDA)
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 - the Schiller Argus Pro PB 1000 Monitor unit.
- Recall number
- Z-1974-2010
- Recalling firm
- McKesson Provider Technologies - Medical Imaging Group
- 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.
- Status
- Terminated
- Initiated
- 2010-04-15
- Posted
- 2010-07-09
- Terminated
- 2010-07-21
- 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 .
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K050561"]
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 3005157178
- Firm city
- Parsippany
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28