medical Class II Updated 2020-02-26

Pentax of America Inc recalls Pentax Video Colonoscope Model: EC34-i10L

Recalled Product

Pentax Video Colonoscope Model: EC34-i10L


Hazard / Issue

Distributed in the USA without an approved 510K

Issued by

FDA

Affected States: NC, MA
Lot/Code Info: Serial Numbers: L110300, L110301, L110303, L110306
View official government recall

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