Recall Z-0700-2007 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Advanced Bionics Corp
The Precision Implantable Pulse Generator, Model Number SC-1110
| Date | Mar 31, 2007 (initiated Jan 30, 2007) |
| Status | Terminated |
| Reason | The Precision Implantable Pulse Generator with firmware Revision 3.01 incorrectly reports an error condition for a valid output from its self internal check. |
| Root cause | Other |
| Action | March 2007 by letter to physicians who had implanted the units notifying them of the recall and future upgrade by wireless RF telemetry. |
| Quantity | 5 unimplanted devices; 52 implanted devices |
| Distribution | Nationwide including Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.