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.
FDA Recall Z-1899-2010 · Posted 2010-06-24
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Recalling FirmMcKesson Provider Technologies - Medical Imaging Group
Recall StatusTerminated
Product CodeDQK
Date Initiated2010-01-27
Date Terminated2010-06-25
Product Quantity22 devices
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Nationwide distribution: CA, CT, FL, LA, NC, TN, WA, and WV.
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.
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