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Pentax of America Inc recalls Pentax Video Colonoscope Model: EC38-i10L
Recalled February 26, 2020 · FDA recall Z-1268-2020 · Pentax of America
Hazard
Distributed in the USA without an approved 510K · FDA Class II
Units
1 unit
Sold at
NC, MA
Description
Distributed in the USA without an approved 510K
Product
Pentax Video Colonoscope Model: EC38-i10L
Manufacturer(s)
Pentax of America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →