FDAMarch 12, 2018device
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. McKesso...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.
What to do
FDA enforcement status: Terminated
Brands named
mckesson israelmckesson
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAUDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-632026-01-16
- FDAGE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global...2025-12-24
- FDASMV DSI, System, Tomography, Computed, Emission2025-12-10
- FDASMV BodyTrack, System, Tomography, Computed, Emission2025-12-10
- FDASMV DSX New Line, System, Tomography, Computed, Emission2025-12-10
- FDAMAXXUS, System, Tomography, Computed, Emission2025-12-10
- FDAMillenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging2025-09-12
- FDAElscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging2025-09-12
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