Medical Device Recall: DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Pro-Med Instruments Gmbh · March 14, 2025
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
217 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1860-2025
Status: ongoing
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