FDA-Device2023-11-01Class II
OPMI LUMERA 300, REF 6137
Carl Zeiss Suzhou Co., Ltd.
Hazard
Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspension arm, which may injure any person under the suspended components.
Sold states
US Nationwide distribution in the states of MD, TX, CA, GA, LA.
Affected count
8
Manufactured in
Modern Industrial Square 3b, No. 333 Xingpu Road; Kunshan, Suzhou, N/A, China
Products
OPMI LUMERA 300, REF 6137
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0183-2024Don't want to check this manually?
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