Horizon Cardiology ECG Management This is a software application designed for use in various hospital departments to imp

FDA device recall Z-0900-2011 · posted 2011-01-13 · Terminated

Recall details

Recalling firm

McKesson Provider Technologies - Medical Imaging Group

Reason for recall

When importing ECG files from Mortara ECG carts using DICOM interface, the Horizon Cardiology ECG Management System does not display the amplitudes of the waveform properly.

Action taken

McKesson Medical sent an advisory notice letter dated June 16, 2010, to all affected customers. Advisory notice ADV01646 was distributed to 13 affected clinical sites from August 30, 2010 to September 28, 2010. The letters identified the product that is affected, the circumstances under which patient safety issue may occur, the risk, and the immediate actions that need to be taken along with a temporary fix. Customers were instructed to use the ECG cart printout to verify results of procedures acquired by Mortara ECG carts. Users should be aware of the problem when referrring to past ECG procedures and when performing a visual comparison with ECG procedures acquired by Mortara ECG carts. Customers should disable the Glasgow Serial Comparison for ECG procedures. McKesson Support would contact the customer to coordinate the deployment of the software update on all the affected applications and Horizon Cardiology client applications. For any questions regarding this recall, customers should call the Customer Support department at 1-866-777-0202 and speak to their Support Manager.

Root cause

Device Design

Status

Terminated

Product code

DQK

Quantity affected

16 units

Distribution

Nationwide Distribution including AZ, CA, FL, GA, MA, PA, UT, and WI.

Date initiated

2010-06-16

Date posted

2011-01-13

Date terminated

2012-08-17

Location

Parsippany, NJ