Linvatec LS 7500, 300 Watt Xenon Light Source Catalog Numbers: LS7500, LS7500L (loaner), LS7500R (refurbished)
FDA device recall Z-1531-05 · posted 2005-09-10 · Terminated
Recall details
- Recalling firm
- Linvatec Imaging
- Reason for recall
- 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
- Status
- Terminated
- Product code
- GCT
- Quantity affected
- 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, S
- Date initiated
- 2005-08-01
- Date posted
- 2005-09-10
- Date terminated
- 2012-04-16
- Location
- Santa Barbara, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LINVATEC 300W XENON LIGHT SOURCE (K031994) | Linvatec Corp. | 2003-08-21 |