Z-1899-2010

Horizon Cardiology Hemo Monitoring System A programmable diagnostic computer intended for acquiring...

Name: Z-1899-2010 Horizon Cardiology Hemo Monitoring System A programmable diagnostic computer intended for acquiring...
Creator: McKesson Provider Technologies - Medical Imaging Group
Published: 2010-01-27
License: https://open.fda.gov/license/

Change Healthcare Technologies LLC / initiated 2010-01-27 / Terminated / root cause: software

FDA source

McKesson Provider Technologies - Medical Imaging Group began a recall of Horizon Cardiology Hemo Monitoring System A programmable diagnostic computer intended for acquiring digitizing, storing, displaying , and reviewing hemodynamic... on 2010-01-27. The reason FDA records is "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...". 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-1899-2010
Status: Terminated
Initiated: 2010-01-27
Posted: 2010-06-24
Terminated: 2010-06-25
Recalling firm: Change Healthcare Technologies LLC
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.
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: 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 tag: software
FDA 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 in commerce: 22 devices
Distribution: Nationwide distribution: CA, CT, FL, LA, NC, TN, WA, and WV.
Product codes and lots: Serial numbers: 2008052847, 2008072107, 2008092609, 2008092608, 2009010800, 2008121714, 2008101609, 2008101608, 2008101618, 2008110391, 2008110390, 2008110389, 2009020226, 2009020227, 2009030603, 2009030602, 2009030601, 2009110399, 2008110398, 2008051520, 2008051519, 2008051518.

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)