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The software defect could cause neurosurgeons to damage a patient’s healthy brain tissue.
Synergy Cranial Software and Stealth Station S7 Cranial Software has been recalled by Medtronic due to inaccuracies displayed during surgical procedures, according to the U.S. Food and Drug Administration (FDA).
The software, when used with the StealthStation Surgical Navigation System, provides 3D images of a patient’s brain to help neurosurgeons navigate surgical tools and implants used during surgery.
Medtronic recalled the software due to reports that it displays incorrect information during biopsy procedures that could result in serious or life-threatening patient harm — that’s why the FDA has classified this as a Class 1 recall.
During the procedure, the software monitor may show that the tip of the surgical tool has not reached the target and could prevent the neurosurgeon from accurately seeing the location of the tools in the patient’s brain. If this happens, the surgeon could potentially insert the tool too deeply, damaging the patient’s healthy tissue, brain or blood vessels.
Neurosurgeons using models manufactured and distributed between Aug. 31, 2011 and Oct. 16, 2018 are at risk of having the faulty software.
Medtronic sent an urgent medical device correction notice to customers on Sept. 21, and the recall was initiated on Sept. 26.
The notice was sent to eliminate the risk of the software. It instructed customers to not set a projection longer than the length of the surgical plan, to follow the Cranial Software Pocket Guide, to always use the biopsy needle mechanical depth stop, and to ensure the navigate instrument tip setting is selected before locking the trajectory and navigating the instrument.
Customers were also told to tell their staff about the issue and to sign a consignee response form that was attached to the notice.
Medtronic has continued to follow up with customers about their correction plan for the software.
This recall is just the latest for Medtronic, who recalled its Puritan Bennett 980 ventilator in December.
While this software issue can be harmful or deadly for the patient if the defect occurs, other software vulnerabilities could put patient data or safety at harm.
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