# FDA recall Z-2968-2018

> **McKesson Israel Ltd.** · Class II · device recall initiated 2018-03-12.

## 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 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.

## Reason for recall

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

## 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.

## Key facts

- **Recall number:** Z-2968-2018
- **Recalling firm:** McKesson Israel Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-12
- **Report date:** 2018-09-12
- **Termination date:** 2021-11-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tel Aviv, N/A, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2968-2018

## Citation

> AI Analytics. FDA recall Z-2968-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2968-2018. Source: US FDA. Licensed CC0.

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