The FDA has issued a Class I designation over McKesson Technologies Inc.'s recall of its McKesson Anesthesia Care, a computer-based system used in environments such as operating rooms. An anesthesia provider uses the system to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care. But there was an occurrence where a patient’s data in the system included information from another case, the FDA said when announcing the Class I designation on Friday. FDA officials think mismatch of patient data related to anesthesia delivery could cause serious injury or death.
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