The Food and Drug Administration has assigned a formal recall classification to a software problem that could remove hospital patients from the system monitoring their vital signs and has rewritten its explanation of why the action was taken.
On September 3, the agency classified the GE HealthCare Portrait Core Services issue as a Class II recall. That designation means regulators concluded the problem may cause temporary or reversible health problems, or, though unlikely, serious ones. It sits below Class I, the tier reserved for defects the agency believes could cause serious injury or death.
