Users complained that Medtronic software displays material that misleads neurosurgeons to false directions, prompting the Class I recall.
A Medtronic program used to locate anatomical features during brain surgery has been the subject of a Class I recall by the US Food and Drug Administration (FDA) due to the discovery of defective text that might possibly mislead surgeons.
Four different versions of Medtronic’s StealthStation S8 application, intended for use with a surgical drill, were subject to a Class I recall, the most serious kind of recall, following customer complaints about a software error that resulted in numbers or letters missing from the displayed text and being replaced by a space. This could lead to the surgeon placing the biopsy tip stop during navigation in neurosurgery using the wrong measurement.
According to the FDA, carrying out a cranial operation with an erroneous placement could result in death or serious, lifelong injuries such brain, nerve, or cerebrovascular damage, aberrant brain, spine, or muscle functions, or paralysis.
According to Medtronic, they have received 28 reports regarding the problem; however, no fatalities or injuries have been reported as a result of the incident. The business has since sent out a letter titled “Urgent Medical Device Correction,” in which it declares that a free software upgrade that specifically addresses the problem is being developed. The software versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 are impacted.
It comes nearly a year after Medtronic issued a Class I recall for a portion of its cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs) because the devices weren’t emitting enough energy.
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