Recall Z-3091-2011 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Advanced Neuromodulation Systems
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.
| Date | Aug 30, 2011 (initiated Jun 2, 2009) |
| Status | Terminated |
| Reason | Product programmed with unapproved software was distributed. |
| Root cause | Software change control |
| Action | 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. |
| Quantity | 14 units |
| Distribution | Distributed in New Hampshire and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.