FDA-Device2025-06-04Class II
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Pro-Med Instruments Gmbh
Hazard
Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.
Sold states
Worldwide - US Nationwide distribution in the states of CA, CO, KY, ID, IL, MA, MO, NC, NJ, NY, TX and the countries of Algeria, Argentina, Australia, Austria, Brazil, Burma, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Mexico, Mongolia, Netherlands, Norway, Philippines, Poland, Qatar, Russia, Russia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom.
Affected count
217 units
Manufactured in
BOETZINGER STRASSE 86, N/A, Freiburg Im Breisgau, N/A, Germany
Products
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1860-2025Don't want to check this manually?
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