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***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source

FDA Recall #Z-2455-2012 — Class II — May 20, 2011

Recall #Z-2455-2012 Date: May 20, 2011 Classification: Class II Status: Terminated

Product Description

***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon 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

1

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.

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