FDA (Devices) recall action 96025
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
A software defect in Change Healthcare Cardiology Hemo software may cause clinicians to administer incorrect medications. The defect affects the autosave mechanism in affected versions.
A software defect in McKesson Cardiology Hemo's autosave mechanism may cause clinicians to administer incorrect medications. The FDA has issued a Class II recall.
A software defect in Change Healthcare's Cardiology Hemodynamics software may cause clinicians to administer incorrect medications. The defect affects an autosave mechanism and has been distributed nationwide and internationally.