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Pro-Med Instruments Gmbh recalls DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Recalled June 4, 2025 · FDA recall Z-1860-2025 · Pro-Med Instruments
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. · FDA Class II
Units
217 units
Sold at
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.
Description
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.
Product
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Manufacturer(s)
Pro-Med Instruments Gmbh
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →