Device Recall Image1 SPIES XLINK Camera Control Unit (CCU)

NT743473-P NT743472-P NT742840-P XU738911-P YU741045-P XU738248-P WU737260-P PV715203-P PV715207-P NT742829-P XU738899-P WU737275-P YV724235-P WU737269-P WU737268-P VU736411-P XU738901-P XU738910-P ZU742677-P YU741050-P VU736405-P TU733422-P TU733419-P SU733063-P VU736390-P VU736386-P UU734392-P RV716122-P OT744400-P NT743287-P OT744395-P NU727551-P NU727552-P NU727706-P TU734218-P TU734217-P NT742846-P YU741046-P OU728667-P TU733735-P VU736388-P NT742848-P NT742838-P OU728672-P OU728427-P WU737813-P OU729135-P OU728431-P OU728430-P WU737805-P ZU742670-P ZU742671-P YU741049-P YU740475-P ZU742681-P RV716116-P SU733055-P SU733057-P SU733059-P SU733060-P TU733418-P TU733420-P TU733421-P TU733423-P TU733424-P TU733425-P TU733427-P WU737810-P XU738914-P YU740004-P YU740471-P YU740479-P YU740480-P YU741036-P NV711744-P PV715216-P OU728670-P NU726430-P OT744399-P OT744389-P OT744386-P YU739999-P YU740003-P YU740005-P UU734395-P YV724443-P YV724442-P YV724440-P YV724438-P YV724245-P

Gastroenterology-Urology Devices

2

No

Worldwide Distribution - US Distribution to the states of : IL, NM, TX, MD, TN, PA, FL, KY, MO, NY, MN, DC, MA, WI, CT, MI, ID, CO, GA, NJ and AR., and to the countries of : Argentina, Australia, Belgium, Bulgaria, China, Germany, Finland, Great Britain, India, Italy and Japan.

Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope