McKesson Israel Ltd.: Medical Device Recall in 2018 - (Recall #: Z-2968-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 analytical assessment. McKesson Cardiology Hemo is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data.

Product Classification:

Class II

Date Initiated: March 12, 2018

Date Posted: September 12, 2018

Recall Number: Z-2968-2018

Event ID: 80723

Reason for Recall:

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

Status: Terminated

Product Quantity: 31 units

Code Information:

software versions: 13.0 HF1, 13.0HF2, 13.0HF3

Distribution Pattern:

US Distribution to states of: CA, CO, CT, FL, GA, KS, IN, LA, NJ, NY, OK, OH, SC, and TX; and internationally to: UK.

Voluntary or Mandated:

Voluntary: Firm initiated