Recall Z-1409-2010 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Boston Scientific Neuromodulation Corporation
Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4
| Date | Apr 16, 2010 (initiated Mar 19, 2010) |
| Status | Terminated |
| Reason | Toshiba has determined that certain Sony battery packs installed in Toshiba portable computers can overheat, posing fire hazard to customers. Based on Toshiba's investigation with Sony Corporation, they concluded that the battery cells in specific manufacturing lots could be affected. |
| Root cause | Other |
| Action | In a letter dated March 19, 2010 Boston Scientific informed consignees that it determined that certain Sony battery packs installed in Toshiba portable computers can overheat, posing fire hazard to customers, and telling them that they may be in possession of an affected product. They were advised that a Boston Scientific representative will contact them to arrange for an inspection of the Clinician Programmer (SC-7150-4). Until they have determined if the battery pack is affected, consignees were told they can only use their Toshiba portable computer with the original AC adapter power cord |
| Quantity | 62 units |
| Distribution | Domestically to AR, CA, CO, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NY, OH, OR, PA, PR, SC, TX, VA, WI Internationally: Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.