FDA Device recall Z-3067-2017

Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by…

FDA Device
Class II
terminated
Published 2017-08-30

On 2017-08-30 the FDA classified a Class II recall of Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by… by Pentax, citing error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-3067-2017
Classification	Class II
Status	terminated
Initiated	2017-05-23
Published	2017-08-30
Last updated	2026-09-13 11:54 UTC
Company	Pentax
Distribution	US

Product

Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

Reason

Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. The disinfecting solution, not the cleaning detergent, should be used for this step.

Identifiers

code_info	Serial Numbers: G110307, H110482, H110484, H110487, H110489, G110334, G110338, G110404, G110296, G110358, G110340, G110… Serial Numbers: G110307, H110482, H110484, H110487, H110489, G110334, G110338, G110404, G110296, G110358, G110340, G110341, G110407, G110409, H110432, G110345, H110450, G110391, H110476, H110443, H110446, G110400, H110483, G110394, G110406, H110411, H110497, G110360, G110363, G110364, G110371, G110366, G110368, G110372, H110434, H110447, G110380, H110455, G110298, H110445, H110449, H110461, G110292, G110346, G110365, H110494, H110495, H110474, G110376, G110319, G110328, H110473, H110413, H110414, H110427, H110453, H110454, H110415, G110312, G110321, H110467, H110471, H110412, G110289, G110303, G110294, H110420, G110299, G110300, H110448, H110452, G110386, G110331, H110451, H110493, G110313, G110314, H110464, H110496, H110433, G110373, G110375, G110317, H110431, H110417, G110291, G110302, G110369, G110378, G110335, G110387, G110390, G110392, G110395, G110311, G110327, G110332, G110382, G110355, G110357, G110287, G110320, H110435, H110481, H110485, H110486, G110354

code_info

Serial Numbers: G110307, H110482, H110484, H110487, H110489, G110334, G110338, G110404, G110296, G110358, G110340, G110…

Serial Numbers: G110307, H110482, H110484, H110487, H110489, G110334, G110338, G110404, G110296, G110358, G110340, G110341, G110407, G110409, H110432, G110345, H110450, G110391, H110476, H110443, H110446, G110400, H110483, G110394, G110406, H110411, H110497, G110360, G110363, G110364, G110371, G110366, G110368, G110372, H110434, H110447, G110380, H110455, G110298, H110445, H110449, H110461, G110292, G110346, G110365, H110494, H110495, H110474, G110376, G110319, G110328, H110473, H110413, H110414, H110427, H110453, H110454, H110415, G110312, G110321, H110467, H110471, H110412, G110289, G110303, G110294, H110420, G110299, G110300, H110448, H110452, G110386, G110331, H110451, H110493, G110313, G110314, H110464, H110496, H110433, G110373, G110375, G110317, H110431, H110417, G110291, G110302, G110369, G110378, G110335, G110387, G110390, G110392, G110395, G110311, G110327, G110332, G110382, G110355, G110357, G110287, G110320, H110435, H110481, H110485, H110486, G110354

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3067-2017%22

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