FDA Medical Device Recalls (openFDA)
McKesson Provider Technologies - Medical Imaging Group: Horizon Cardiology Hemo Monitoring System A programmable diagnostic computer intended for acquiring digitizing, storing, displaying , and reviewing hemodynamic data for use in hospital cardiac catherization laboratories.
- Recall number
- Z-1899-2010
- Recalling firm
- McKesson Provider Technologies - Medical Imaging Group
- Product
- Horizon Cardiology Hemo Monitoring System A programmable diagnostic computer intended for acquiring digitizing, storing, displaying , and reviewing hemodynamic data for use in hospital cardiac catherization laboratories.
- Status
- Terminated
- Initiated
- 2010-01-27
- Posted
- 2010-06-24
- Terminated
- 2010-06-25
- Reason
- McKesson has identified a potential hardware configuration problem in some Horizon Cardiology Hemo systems which may cause delay and/or loss of the patient's physiological parameters on the Horizon Cardiology Hemo screen and on the patient record.
- Root cause
- Software design
- Action
- The firm, McKesson Israel Ltd., sent notification letter dated January 27, 2010 to customers. The letter describes the product, problem and action to be taken by customers and the firm. McKesson's will be contacting the customer to coordinate replacement of the sound component of the Horizon Cardiology Hemo system and will provide the additional sound adapter for all affected systems at your facility at not cost. The customers were instructed to pleasel immediately conduct the following instructions to disable sound operations-1) Open McKesson Management Console and locate the Windsurfer>Monitor Settings; 2) Uncheck "Enable QRS beep" in the sounds section; 3) Locate Windsufer>Hardware Settings in McKesson Management Console, and 4) Uncheck "Enable QRS beep" in the Analog Output, QRS Beep Section. If you have any questions, please do not hesitate to contact Ronen Gans directly at (973) 355-9900.
- Quantity
- 22 devices
- Distribution
- Nationwide distribution: CA, CT, FL, LA, NC, TN, WA, and WV.
- Lot, serial or model codes
- Serial numbers: 2008052847, 2008072107, 2008092609, 2008092608, 2009010800, 2008121714, 2008101609, 2008101608, 2008101618, 2008110391, 2008110390, 2008110389, 2009020226, 2009020227, 2009030603, 2009030602, 2009030601, 2009110399, 2008110398, 2008051520, 2008051519, 2008051518.
- 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
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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