Z-0900-2011

Horizon Cardiology ECG Management This is a software application designed for use in various hospital...

Name: Z-0900-2011 Horizon Cardiology ECG Management This is a software application designed for use in various hospital...
Creator: McKesson Provider Technologies - Medical Imaging Group
Published: 2010-06-16
License: https://open.fda.gov/license/

Change Healthcare Technologies LLC / initiated 2010-06-16 / Terminated / root cause: design

FDA source

McKesson Provider Technologies - Medical Imaging Group began a recall of Horizon Cardiology ECG Management This is a software application designed for use in various hospital departments to import, display, store, analyze... on 2010-06-16. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0900-2011
Status: Terminated
Initiated: 2010-06-16
Posted: 2011-01-13
Terminated: 2012-08-17
Recalling firm: Change Healthcare Technologies LLC
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.
Product code: DQK Computer, Diagnostic, Programmable
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.
Root cause tag: design
FDA 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 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.
Quantity in commerce: 16 units
Distribution: Nationwide Distribution including AZ, CA, FL, GA, MA, PA, UT, and WI.
Product codes and lots: K061905; Versions 12, 12 SP1, 12 SP1 HF2, 12 SP1 HF4, 12.1, 12.1 HF1, 12.1 HF2

Product code DQK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)