Class 2 Device Recall Ultrasound Video Gastroscope, Model EG3670URK

• Date Initiated by Firm: May 23, 2017
• Create Date: August 23, 2017
• Recall Status: Terminated on May 21, 2020
• Recall Number: Z-3067-2017
• Recall Event ID: 77380
• 510(K)Number: K061068 K090196 K130706
• Product Classification: Endoscopic ultrasound system, gastroenterology-urology - Product Code ODG
• 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.
• 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.
• Recalling Firm/ Manufacturer: Pentax of America Inc; 3 Paragon Dr; Montvale NJ 07645-1782
• For Additional Information Contact: Paul Silva; 973-628-2199
• Manufacturer 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.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = ODG and Original Applicant = MR INSTRUMENTS, INC.; 510(K)s with Product Code = ODG and Original Applicant = PENTAX MEDICAL COMPANY