MDT - Medtronic Issues Class I Recall For Its Surgical Navigation Software Due To Glitch | Benzinga
Medtronic Plc (NYSE: MDT) recalled StealthStation S8 Application Version 2.0 and 2.0.1 due to a software glitch that can make the surgical plan data shift location(s) after the initial test is changed.
The glitch can cause the surgical plan data to be in an unintended location for the surgery.
The FDA deemed the recall of StealthStation S8 software Class I, the most serious kind.
The use of the affected product may cause serious adverse health consequences, including death.
There have ...