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Medtronic Recalls StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 for Software Error that May Cause Incorrect Measurements During Cranial Surgery
Medtronic is recalling the StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 after customer complaints about a software error causing numbers or letters to be missing from the displayed text and replaced by a space, in either the "distance to target" or "tip stop point" display during navigation.
The missing digit may result in the mechanical depth stop being set too short or too long and may cause the surgeon to use an incorrect measurement for placement of the biopsy tip stop during navigation.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death. Please be aware, this recall is a correction, not a product removal.
Questions?
Customers with questions related to this issue should contact Medtronic Technical Services for help at 1-888-826-5603 or email at rs.navtechsupport@medtronic.com.
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