FDAClass IIApril 15, 2020

McKesson Cardiology ECG Management recall

McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management

Why was McKesson Cardiology ECG Management recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
Recalling firm
CHANGE HEALTHCARE CANADA COMPANY
Quantity
51 units
Distribution
Distribution US nationwide, Canada and the United Kingdom
Recall date
April 15, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls