Recall Z-0873-2007 ยท KOG
Vision Systems Group, A Div of Viking Systems
Light Source 300 Watt Xenon Lamp used in the following models: Viking EndoSite Xenon, Model 8050-1 and Boston Scientific Spyglass 300W Light Source (M00546190)
| Date | Jun 6, 2007 (initiated Apr 5, 2007) |
| Status | Terminated |
| Reason | Incorrect power entry module assembled into unit may cause burning to insulation, compromised electrical emissions and premature light source failure |
| Root cause | Nonconforming Material/Component |
| Action | Viking notified 2 distributors and 1 end user by telephone on 3/15/07. Viking representatives performed on site visit to perform inspection and replace units if needed. |
| Quantity | 4 |
| Distribution | Nationwide to CA and NC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K864385 | LUXTEC LIGHT SOURCES Luxtec Corp., Jan 13, 1987 |