Recall Z-1531-05 ยท GCT Light Source, Endoscope, Xenon Arc
Linvatec Imaging
Linvatec LS 7500, 300 Watt Xenon Light Source Catalog Numbers: LS7500, LS7500L (loaner), LS7500R (refurbished)
| Date | Sep 10, 2005 (initiated Aug 1, 2005) |
| Status | Terminated |
| Reason | Through the complaint handling system, the company has determine there are performance issued involving the LS7500, 300 Watt Xenon Light Source. The performance issues result in a low light output that can create poor illumination of the surgical site. |
| Root cause | Nonconforming Material/Component |
| Quantity | 810 units |
| Distribution | Nationwide and Australia, Belgium, Brazil, Canada, Chile, China, Denmark, France, Germany, Italy, Japan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey, United Arab Emirates, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031994 | LINVATEC 300W XENON LIGHT SOURCE Linvatec Corp., Aug 21, 2003 |