Z-1682-2020Class II

McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management

Name: Z-1682-2020 McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
Creator: Change Healthcare Canada Company
Published: 2020-02-10
License: https://open.fda.gov/license/

Change Healthcare Canada Company / initiated 2020-02-10 / Open, Classified / root cause: design

FDA source

CHANGE HEALTHCARE CANADA COMPANY began a recall of McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management on 2020-02-10. FDA classified it as Class II and gives the reason as "Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1682-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-02-10
Posted: 2020-04-08
Recalling firm: Change Healthcare Canada Company
Product: McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format
Root cause tag: design
FDA root cause: Device Design
Action: Change Healthcare Canada Company notified customers on about 02/10/2020 via "Urgent Field Safety Notice" letter. Customers were informed of an issue whereby users who are estimating heart rate by counting grid squares, may assume that the Sequential ECG format is presented on a scale of 25 mm/sec and thereby may inaccurately estimate the heart rate value. Instructions included that the Simultaneous ECG format can be used rather than the Sequential ECG format, until the software is updated and the Sequential ECG format option can be used while maintaining awareness to the scale bar on the screen. Customers were also instructed to contact their users and train them on how to verify the ECG format mode they are working on and how they can change it. The notice needs to be distributed to all those within their organization who need to be aware and to please alert other parties affiliated with your organization that are affected by this field safety notice. Additionally, customers were informed that Change Healthcare is developing a software update that will enable presentation of the Sequential ECG format view using the 25 mm/sec scale and were requested to contact Change Healthcare Customer Support to: 1) Acknowledge they have read and understood this Urgent Field Safety Notice and 2) Arrange installation of software update/upgrade. Change Healthcare Customer Support contacts: - US / Canada: 1 866-777-0202 - UK / Ireland: +44 (0) 208 9527399
Quantity in commerce: 51 units
Distribution: Distribution US nationwide, Canada and the United Kingdom
Product codes and lots: McKesson Cardiology Software Versions: 13.2.1 HF1, 13.2.1 HF2, 14.0, 14.0 HF1, 14.0 HF2; Change Healthcare Software Versions: 14.1.1, 14.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1682-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1682-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-15	2020-04-08

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)