KleenSpec corded illumination system

md

Details on affected devices: Model: 78810, 78812, 78814, 78816, 79910, 79912, 79914 and 79916 Affected Devices: All KleenSpec® Corded Illumination Systems can be affected, regardless of lot.

illumination System

Medical instruments for use in humans - gynaecology

78810, 78812, 78814, 78816 | All manufactured between 02/2004 and 08/2015

MD: General-purpose light source

all lots

Obstetrical and Gynecological Devices

2

No

Nationwide, Puerto Rico and foreign distribution to the following countries: Australia, Bahamas, Bahrain, Belgium, Bermuda, Cambodia, Canada, Czech Republic, China, Cyprus, Denmark, Egypt, France, Germany, Great Britain, Greece, Guam, Guatemala, Iceland, India, Israel, Japan, Kenya, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sri Lanka, Thailand, Turkey, United Arab Emirates.

Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalog Numbers 78800, 73410, 73412, 73414, 73416, 78810, 78812, 78814 and 78816, Rx ONLY