Recall Z-0900-2011 ยท DQK Computer, Diagnostic, Programmable
McKesson Provider Technologies - Medical Imaging Group
Horizon Cardiology ECG Management This is a software application designed for use in various hospital departments to import, display, store, analyze, distribute, and process ECG procedures from resting ECG devices. It is also intended to provide analysis or reanalysis or testings ECGs and to provide preliminary data for editing and confirmation by an over-reading physician. Horizon Cardiology ECG
| Date | Jan 13, 2011 (initiated Jun 16, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 16 units |
| Distribution | Nationwide Distribution including AZ, CA, FL, GA, MA, PA, UT, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.