Pro-Med Instruments Gmbh recalls DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

Recall date

March 14, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1860-2025

FDA classification

Class II

Brand / firm

Pro-Med Instruments Gmbh

Sold / distributed

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,…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)