Horizon Cardiology Hemo Monitoring System A programmable diagnostic computer intended for acquiring digitizing, storing,

FDA device recall Z-1899-2010 · posted 2010-06-24 · Terminated

Recall details

Recalling firm

McKesson Provider Technologies - Medical Imaging Group

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.

Action taken

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

Status

Terminated

Product code

DQK

Quantity affected

22 devices

Distribution

Nationwide distribution: CA, CT, FL, LA, NC, TN, WA, and WV.

Date initiated

2010-01-27

Date posted

2010-06-24

Date terminated

2010-06-25

Location

Parsippany, NJ

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