Stealth Station Recalls

Why is it so hard to get your **** together Medtronic? This is the third software recall in like a year.

Should I just go ahead and call BrainLab now?

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There's actually more info about the recall

Synergy Cranial Software and Stealth Station S7 Cranial Software due to a defect where incorrect information is displayed related to the depth of the surgical tool in the brain, specifically, showing that the tip of the device has not yet reached the planned target when, in fact, it is already there. If the defect occurs, the surgeon, under the impression that he has yet to reach the target, may insert the tool too deeply and damage healthy brain tissue or blood vessels.

Accuracy is the one and only requirement for nav software and our developers can't even do that right. Can you imagine being a sales rep and having to sell a product that incorrectly displays the depth of a surgical tool in the brain? How could you live with yourself if the product fails during a procedure you're covering?

With such a serious recall and problems with accuracy, why hasn't Stealth and its software been pulled from GPOs and other contracts until it's been resolved?

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The field has known this for a while but there was another one as well more recently.

Medtronic is recalling the Synergy Cranial Software and StealthStation S7 Cranial Software used with the StealthStation Surgical Navigation System due to reports of incorrect information displaying during biopsy procedures that could result in serious or life-threatening patient harm.

During a biopsy procedure, the software monitor may show that the tip of the surgical tool has not yet reached the planned target and may prevent the neurosurgeon from being able to accurately see the location of surgical tools in the patient's brain. In the event this software defect occurs, the neurosurgeon could potentially insert the surgical tool too deeply and damage the patient's healthy tissue, brain or blood vessels.

There's actually more info about the recall

Synergy Cranial Software and Stealth Station S7 Cranial Software due to a defect where incorrect information is displayed related to the depth of the surgical tool in the brain, specifically, showing that the tip of the device has not yet reached the planned target when, in fact, it is already there. If the defect occurs, the surgeon, under the impression that he has yet to reach the target, may insert the tool too deeply and damage healthy brain tissue or blood vessels.

Accuracy is the one and only requirement for nav software and our developers can't even do that right. Can you imagine being a sales rep and having to sell a product that incorrectly displays the depth of a surgical tool in the brain? How could you live with yourself if the product fails during a procedure you're covering?

post

The field has known this for a while but there was another one as well more recently.

Medtronic is recalling the Synergy Cranial Software and StealthStation S7 Cranial Software used with the StealthStation Surgical Navigation System due to reports of incorrect information displaying during biopsy procedures that could result in serious or life-threatening patient harm.

During a biopsy procedure, the software monitor may show that the tip of the surgical tool has not yet reached the planned target and may prevent the neurosurgeon from being able to accurately see the location of surgical tools in the patient's brain. In the event this software defect occurs, the neurosurgeon could potentially insert the surgical tool too deeply and damage the patient's healthy tissue, brain or blood vessels.

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A Class 1 recall is a terrible look.

Great. Will this affect ENT at all?

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