FDA-Device2026-07-08Class II
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Hazard
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Sold states
Worldwide - US Nationwide distribution in the state and territories of Florida and Puerto Rico. The countries of China, Germany, Ecuador, Spain, France, Malaysia, Philippines, Poland, and Romania.
Affected count
13 units
Manufactured in
Rudolf-Eber-Str. 11, N/A, Oberkochen, N/A, Germany
Products
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2649-2026Don't want to check this manually?
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