FDAClass IISeptember 12, 2018

McKesson Cardiology Hemo recall

McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended…

Why was McKesson Cardiology Hemo recalled?

Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

software versions: 13.0 HF1, 13.0HF2, 13.0HF3

Product
McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended…
Recalling firm
McKesson Israel Ltd.
Quantity
31 units
Distribution
US Distribution to states of: CA, CO, CT, FL, GA, KS, IN, LA, NJ, NY, OK, OH, SC, and TX; and internationally to: UK.
Recall date
September 12, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls