McKesson Cardiology Hemo — Class II medical device recall Z-2968-2018
Terminated recall by McKesson Israel Ltd., reported 2018-09-12, distributed in CA, CO, CT, FL, GA, IN, KS, LA…. Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may
| Recall number | Z-2968-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | McKesson Israel Ltd., Tel Aviv, N/A, Israel |
| Recall initiated | 2018-03-12 |
| Classified | 2018-08-31 |
| Reported by FDA | 2018-09-12 |
| Terminated | 2021-11-23 |
| Distributed | CA, CO, CT, FL, GA, IN, KS, LA, NJ, NY, OH, OK, SC, TX |
| Countries outside the US | GB |
| Quantity | 31 units |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2968-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.