The Food and Drug Administration on March 14 issued a Class 1 recall notice to healthcare professionals for the Anesthesia Care software of McKesson Corp. The software collects, processes, and records data both through manual entry and from monitors which are attached to patients, such as in an operating room environment. San Francisco-based McKesson had initiated a voluntary Class II recall of the product last year.
The Class I recall is in the FDAs highest risk category which is reserved for defects where there is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death. It is not often that the regulatory agency issues this kind of recall notice for standalone software that does not play a role in operating a medical device. However, the software provides clinical decision support by communicating potential adverse drug event alerts proactively during the pre-anesthesia evaluation and at the point-of-care, the FDA said in the notice.
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