***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
FDA Recall #Z-2456-2012 — Class II — May 20, 2011
Product Description
***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
Reason for Recall
Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures.
Recalling Firm
Linvatec Corp. dba ConMed Linvatec — Largo, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
57
Distribution
Worldwide Distribution - US Nationwide and the countries of Canada, DK, HK, IN, IT, KR, MY, RU, CO, VN, ZA.
Code Information
GCT
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.