Exact FDA event identifier

Event 77380

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: May 23, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Pentax of America Inc

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-3067-2017

Recall number: Z-3067-2017
Initiated: May 23, 2017
Classification: Class II
Status: Terminated
Recalling firm: Pentax of America Inc
Quantity: US: 118 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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, G110316, G110318, G110362, G110393, H110498, H110456, H110457, H110459, G110337, G110356, H110421, H110429, G110290, G110352, H110470, H110478, G110383, G110384, G110361.

Distribution pattern

Nationwide

device · product 2 of 2

Ultrasound Video Gastroscope, Model EG-3870UTK. 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.

Z-3068-2017

Recall number: Z-3068-2017
Initiated: May 23, 2017
Classification: Class II
Status: Terminated
Recalling firm: Pentax of America Inc
Quantity: US: 116 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

H110516, H110619, H110635, H110643, H110624, A110407, A110411, H110507, A110352, A110444, A110417, A110419, H110493, H110494, H110522, H110584, H110586, H110590, H110591, H110559, A110471, A110474, A110355, A110359, H110606, H110566, H110568, H110498, H110503, H110509, H110510, H110637, H110560, H110514, A110427, A110372, A110438, H110587, H110598, H110600, A110439, A110440, A110443, A110450, A110448, A110451, A110453, H110542, H110569, A110445, A110454, H110565, A110356, A110357, H110592, H110593, H110595, A110346, H110508, A110461, H110620, H110623, H110641, H110642, H110613, A110460, A110380, A110463, H110577, A110457, A110401, H110610, H110611, H110502, H110511, H110518, H110519, H110578, H110557, H110561, A110422, A110432, H110512, H110626, H110628, H110629, H110633, H110634, H110539, H110544, A110341, A110418, H110596, H110604, A110387, A110388, H110601, H110615, H110571, H110574, H110599, H110506, A110350, A110398, H110575, A110449, A110360, A110363, A110368, H110554, H110515, H110567, A110410, A110414, A110485, H110553, H110563, H110589, A110376, A110384, H110549, H110564, H110556, H110536, H110646, H110533, H110543, A110458, A110459, A110383, H110538, H110499, A110344, A110345, A110348, A110452, A110391, A110475, A110483, A110486, A110488, A110477, A110479, A110480, A110481, A110482, A110375, A110406, A110470, A110429, A110435, H110618, A110393, A110394, A110447, A110462, A110466, H110555, H110631, H110636, H110639, H110524, H110525, H110526, H110530, H110531, H110532, H110534, H110535, A110476, A110416, A110420, A110379, A110381, A110385, A110484, A110492, H110640, H110579, H110581, H110572, H110573, A110425, A110431, A110441, A110442, H110517, A110426, A110433, A110434, A110353, H110614, H110616, A110464, A110465, H110520, H110523, H110550.

Distribution pattern

Nationwide