Z-3067-2017Class II

Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the...

Name: Z-3067-2017 Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the...
Creator: Pentax of America Inc
Published: 2017-05-23
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2017-05-23 / Terminated / root cause: labeling and UDI

FDA source

Pentax of America Inc began a recall of Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical... on 2017-05-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3067-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-23
Posted: 2017-08-23
Terminated: 2020-05-21
Recalling firm: PENTAX of America, Inc.
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.
Product code: ODG Endoscopic Ultrasound System, Gastroenterology-Urology
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Recall Notifications were sent to 104 consignees via USPS Certified Mail on 5/23/2017. Included with the Field Safety letter was the customer response form, and the addendum to IFU Z845. These were also posted on Pentax of America web page until the recall is closed.
Quantity in commerce: US: 118 units
Distribution: Nationwide
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3067-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3067-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-30	2017-08-23
Z-3068-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-30	2017-08-23

Product code ODG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)