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Medtronic Navigation Inc. Recalls StealthStation S8 Application Version 2.0 and 2.0.1
Medtronic Navigation Inc. is recalling StealthStation S8 Application Version 2.0 and 2.0.1 due to a software glitch. This can make the surgical plan data shift location(s) after the initial test is changed. This can cause the study plan data to be in an unintended location for the surgery.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Questions?
If you have questions about this recall, contact Medtronic Navigation Inc. at 1-888-826-5603.
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