FDA
Software version 3.3 for Rapid Programmer devices, Model 3832.
Software version 3.3 for Rapid Programmer devices, a personal digital assistant (PDA) based programmer supporting implantable pulse generators of the Eon, Genesis, and Renew family.
Product programmed with unapproved software was distributed.
St. Jude Medical Neuromodulation contacted all affected customers by telephone between June 2, 2009 and June 5, 2009. Customers were given information about the product, problem and action to be taken.
All affected devices were returned to the firm as instructed.