Company: McKesson Provider Technologies .
Date of Enforcement Report 1/19/2011
Class ll:
PRODUCT
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 Management may provide a serial comparison of ECG Data to facilitate the review of the patient’s current ECG with previous ECG’s of the same patient. Recall # Z-0900-2011
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.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated October 16, 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
16
DISTRIBUTION
AZ, CA, FL, GA, MA, PA, UT, WI
