FDA-Device2016-07-13Class II
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
Karl Storz Endoscopy
Hazard
Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera head are used in conjunction with the DCI Video Mediastinocope and an electro-surgery generator (ESG).
Sold states
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.
Affected count
619 units total (90 units in US)
Manufactured in
2151 E Grand Ave, N/A, El Segundo, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2134-2016Don't want to check this manually?
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