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Terminated

Linvatec LS 7500, 300 Watt Xenon Light Source Catalog Numbers: LS7500, LS7500L (loaner), LS7500R (refurbished)

FDA Recall Z-1531-05 · Posted 2005-09-10

Recalling FirmLinvatec Imaging
Recall StatusTerminated
Product CodeGCT
Date Initiated2005-08-01
Date Terminated2012-04-16
Product Quantity810 units

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

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031994LINVATEC 300W XENON LIGHT SOURCELinvatec Corp. · 2003-08-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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