Z-0910-2015Class II

McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze...

Name: Z-0910-2015 McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze...
Creator: McKesson Israel Ltd.
Published: 2014-12-19
License: https://open.fda.gov/license/

Change Healthcare Israel Ltd. / initiated 2014-12-19 / Terminated / root cause: software

FDA source

McKesson Israel Ltd. began a recall of McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG... on 2014-12-19. FDA classified it as Class II and gives the reason as "An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG Management with software versions 13.1 and 13.1.1". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0910-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Posted: 2015-01-05
Terminated: 2016-02-25
Recalling firm: Change Healthcare Israel Ltd.
Product: McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG Management with software versions 13.1 and 13.1.1.
Root cause tag: software
FDA root cause: Software design
Action: McKesson sent an Urgent Field Safety Notice dated December 16, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed how to identify the potentially affected procedures and update the procedure date (if relevant) until a software update is made advailable for installation by McKesson. McKesson will proactively identify prior procedures affected by this issue and will notify customers of any issues identified. In addition to the Field Safety Notice, McKesson Israel will provide correction to the affected SW versions and will contact customers for deployment of a software patch that prevents this scenario from occurring. Customers with questions should contact McKesson Support at 1-866-777-0202. For questions regarding this recall call 404-338-3556.
Quantity in commerce: 9
Distribution: Worldwide Distribution - USA including MA, MS, NH, NC, TX, WA and Internationally to the United Kingdom.
Product codes and lots: MC13.1 and MC13.1.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0910-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0910-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-05

Product code DQK

K113515Class IIHorizon Cardiology ECG ManagementMckesson Israel , Ltd. / cleared 2012-03-16

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)