FDA-Device2018-01-17Class II
Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
Brainlab AG
Hazard
Due to a human error at a supplier, an unknown number of devices within one specific production lot of Brainlab DrapeLink Adapters (Left/Right) were not manufactured according to defined specifications.
Sold states
Distributed in the US to Kansas. Distributed internationally to Australia, Finland, France, Germany, Hong Kong, Ireland, Japan, Netherlands, Norway, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.
Affected count
80 devices total
Manufactured in
Olof-Palme-Strasse 9, N/A, Munich, N/A, Germany
Products
Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0320-2018Don't want to check this manually?
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