FDA Medical Device Recalls (openFDA)
CHANGE HEALTHCARE CANADA COMPANY: McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
- Recall number
- Z-1682-2020
- Recalling firm
- CHANGE HEALTHCARE CANADA COMPANY
- Product
- McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
- Status
- Open, Classified
- Initiated
- 2020-02-10
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- 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
- 51 units
- Distribution
- Distribution US nationwide, Canada and the United Kingdom
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K113515"]
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 3003757840
- Firm city
- Canada
- Firm state
- British Columbia
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28