The Recall Desk
HighFDA (Devices)·Z-2968-2018·Announced 2018-09-12

McKesson Cardiology Hemo Software Recalled for Signal Display Issues

McKesson Israel Ltd. is recalling McKesson Cardiology Hemo software version 13.0 because the Real Time Monitor may fail to display physiological signals under certain circumstances.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device failing to display physiological signals, which poses a risk of harm where injury has not yet been reported.

Plain-English summary

McKesson Israel Ltd. is recalling McKesson Cardiology Hemo, Release SW version 13.0, a software system used for physiological monitoring, image and data processing, and clinical data acquisition. The recall involves 31 units of the software, specifically versions 13.0 HF1, 13.0HF2, and 13.0HF3.

The recall was initiated because Change Healthcare identified an issue where, under certain circumstances, the Real Time Monitor (RTM) component of the software may not display physiological signals. This defect could impact the monitoring capabilities of the device.

The affected software was distributed in the United States to the states of California, Colorado, Connecticut, Florida, Georgia, Kansas, Indiana, Louisiana, New Jersey, New York, Oklahoma, Ohio, South Carolina, and Texas, as well as internationally to the United Kingdom. Users of this software should contact McKesson Israel Ltd. for further instructions regarding the recall.

The recalled product

Product
McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytic
Manufacturer
McKesson Israel Ltd.
Category
Medical Device — Monitoring Software
Hazard
Affected units
31

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • software versions: 13.0 HF1
  • 13.0HF2
  • 13.0HF3

Distribution

Distributed in 14 states:

Related recalls

Same manufacturer · McKesson Israel Ltd.

See all →

Same hazard · display failure

See all →