CHANGE HEALTHCARE CANADA COMPANY: Medical Device Recall in 2020 - (Recall #: Z-1682-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management

Product Classification:

Class II

Date Initiated: February 10, 2020

Date Posted: April 15, 2020

Recall Number: Z-1682-2020

Event ID: 85068

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

Status: Ongoing

Product Quantity: 51 units

Code Information:

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

Distribution Pattern:

Distribution US nationwide, Canada and the United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated