[IGSTK-Developers] FDA issues Class I recall of Stryker Surgical Navigation Systems

[Patrick Cheng]

Hi everyone,

This is an interesting read. It demonstrate the need to build robust 
software in the OR.

http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm193637.htm

Reason for Recall:
The device may suddenly stop working, the screen may freeze, or the 
information may only be updated very slowly.  These problems may affect 
all software products.  These failures could result in delay in surgery, 
rescheduling of the procedure resulting in an additional surgery, risk 
of infection, increased disease symptoms, potential neurological 
problems, or injury due to the surgeon operating in an area where they 
did not intend to operate.  Depending on the type of surgery, these 
failures could potentially lead to serious adverse health consequences, 
including death.

Patrick