FDA Device recall Z-2968-2018
McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing
- FDA Device
- Class II
- terminated
- Published 2018-09-12
On 2018-09-12 the FDA classified a Class II recall of McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing by Mckesson Israel, citing change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2968-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-12 |
| Published | 2018-09-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mckesson Israel |
| Distribution | CA, CO, CT, FL, GA, IN, KS, LA, NJ, NY, OH, OK, SC, TX |
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
Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.
Identifiers
| code_info | software versions: 13.0 HF1, 13.0HF2, 13.0HF3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2968-2018%22
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