Class 2 Device Recall EG3870UTK, Pentax Ultrasound Video Gastroscope

• Date Initiated by Firm: March 14, 2012
• Date Posted: May 03, 2012
• Recall Status: Terminated on July 21, 2015
• Recall Number: Z-1489-2012
• Recall Event ID: 61613
• 510(K)Number: K090197
• Product Classification: Transducer, ultrasonic, diagnostic - Product Code ITX
• Product: EG-3870UTK, Pentax Ultrasound Video Gastroscope. The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide optical visualization via a video monitor of, ultrasonic visualization of, and therapeutic access to the Upper Gastrointestinal Tract, including, but restricted to the organs, tissues, and sub-systems; Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
• Code Information: Marketing Status of Device a. Class : 2 b. PMN : K090197 c. LST : D076884 EG-3870UTK A110013 EG-3870UTK A110014 EG-3870UTK A110015 EG-3870UTK A110016 EG-3870UTK A110018 EG-3870UTK A110021 EG-3870UTK A110022 EG-3870UTK A110023 EG-3870UTK A110024 EG-3870UTK A110025 EG-3870UTK A110026 EG-3870UTK A110028 EG-3870UTK A110029 EG-3870UTK A110030 EG-3870UTK A110031 EG-3870UTK A110033 EG-3870UTK A110034 EG-3870UTK A110035 EG-3870UTK A110038 EG-3870UTK A110040 EG-3870UTK A110041 EG-3870UTK A110042 EG-3870UTK A110044 EG-3870UTK A110045 EG-3870UTK A110046 EG-3870UTK A110047 EG-3870UTK A110048 EG-3870UTK A110050 EG-3870UTK A110051 EG-3870UTK A110052 EG-3870UTK A110053 EG-3870UTK A110054 EG-3870UTK A110055 EG-3870UTK A110056 EG-3870UTK A110057 EG-3870UTK A110058 EG-3870UTK A110059 EG-3870UTK A110060 EG-3870UTK A110061 EG-3870UTK A110062 EG-3870UTK A110063 EG-3870UTK A110064 EG-3870UTK A110065 EG-3870UTK A110066 EG-3870UTK A110067 EG-3870UTK A110068 EG-3870UTK A110069 EG-3870UTK A110070 EG-3870UTK A110071 EG-3870UTK A110075 2008/2/22 EG-3870UTK A110076 2008/2/26 EG-3870UTK A110078 2008/2/28 EG-3870UTK A110080 2008/3/19 EG-3870UTK A110081 2008/3/28 EG-3870UTK A110082 2008/3/28 EG-3870UTK A110083 2008/4/17 EG-3870UTK A110084 2008/5/16 EG-3870UTK A110085 2008/5/16 EG-3870UTK A110086 2008/5/16 EG-3870UTK A110087 2008/5/16 EG-3870UTK A110088 2008/5/21 EG-3870UTK A110090 2008/6/16 EG-3870UTK A110093 2008/8/18 EG-3870UTK A110094 2008/8/18 EG-3870UTK A110095 2008/8/18 EG-3870UTK A110096 2008/8/27 EG-3870UTK A110098 2008/9/5 EG-3870UTK A110099 2008/9/18 EG-3870UTK A110100 2008/9/30 EG-3870UTK A110101 2008/9/29 EG-3870UTK A110104 2008/10/2 EG-3870UTK A110105 2008/10/7 EG-3870UTK A110106 2008/11/11 EG-3870UTK A110107 2008/11/10 EG-3870UTK A110108 2008/11/11 EG-3870UTK A110109 2009/1/13 EG-3870UTK A110110 2008/11/7 EG-3870UTK A110111 2008/11/25 EG-3870UTK A110112 2008/12/8 EG-3870UTK A110113 2008/12/8 EG-3870UTK A110114 2008/12/24 EG-3870UTK A110115 2009/1/30 EG-3870UTK A110116 2009/2/10 EG-3870UTK A110117 2009/2/24 EG-3870UTK A110118 2009/4/21 EG-3870UTK A110119 2009/5/7 EG-3870UTK A110120 2009/4/16 EG-3870UTK A110121 2009/4/28 EG-3870UTK A110122 2009/5/27 EG-3870UTK A110123 2009/6/18 EG-3870UTK A110124 2009/7/25 EG-3870UTK A110125 2009/8/10 EG-3870UTK A110126 2009/8/19 EG-3870UTK A110127 2009/8/5 EG-3870UTK A110128 2009/8/11 EG-3870UTK A110129 2009/9/10 EG-3870UTK A110130 2009/8/11 EG-3870UTK A110131 2009/10/8 EG-3870UTK A110133 2009/8/19 EG-3870UTK A110134 2009/8/25 EG-3870UTK A110135 2009/8/25 EG-3870UTK A110136 2009/8/27 EG-3870UTK A110137 2009/8/28 EG-3870UTK A110138 2009/9/3 EG-3870UTK A110139 2009/9/17 EG-3870UTK A110140 2009/9/17 EG-3870UTK A110141 2009/10/2 EG-3870UTK A110142 2009/10/6 EG-3870UTK A110143 2009/10/15 EG-3870UTK A110144 2009/10/23 EG-3870UTK A110145 2009/11/4 EG-3870UTK A110146 2009/11/10 EG-3870UTK A110147 2009/12/19 EG-3870UTK A110148 2009/12/26 EG-3870UTK A110149 2010/2/26 EG-3870UTK A110150 2010/1/25 EG-3870UTK A110151 2010/1/25 EG-3870UTK A110152 2010/2/2 EG-3870UTK A110153 2010/2/8 EG-3870UTK A110154 2010/2/12 EG-3870UTK A110155 2010/2/19 EG-3870UTK A110156 2010/2/19 EG-3870UTK A110161 2010/3/8 EG-3870UTK A110162 2010/3/8 EG-3870UTK A110163 2010/3/18 EG-3870UTK A110164 2010/4/14 EG-3870UTK A110165 2010/4/16 EG-3870UTK A110166 2010/4/20 EG-3870UTK A110167 2010/4/20 EG-3870UTK A110168 2010/4/21 EG-3870UTK A110169 2010/4/22 EG-3870UTK A110170 2010/4/23 EG-3870UTK A110172 2010/4/28 EG-3870UTK A110173 2010/5/8 EG-3870UTK A110174 2010/5/8 EG-3870UTK A110175 2010/5/10 EG-3870UTK A110177 2010/5/14 EG-3870UTK A110178 2010/5/21 EG-3870UTK A110179 2010/5/26 EG-3870UTK A110180 2010/6/1 EG-3870UTK A110181 2010/6/1 EG-3870UTK A110182 2010/6/8 EG-3870UTK A110183 2010/6/8 EG-3870UTK A110184 2010/6/15 EG-3870UTK A110186 2010/6/22 EG-3870UTK A110192 2010/7/8 EG-3870UTK A110193 2010/7/12 EG-3870UTK A110194 2010/7/13 EG-3870UTK A110195 2010/7/22 EG-3870UTK A110196 2010/7/26 EG-3870UTK A110199 2010/7/29 EG-3870UTK A110200 2010/7/27 EG-3870UTK A110203 2010/8/2 EG-3870UTK A110205 2010/8/6 EG-3870UTK A110206 2010/8/9 EG-3870UTK A110208 2010/9/28 EG-3870UTK A110210 2010/8/30 EG-3870UTK A110211 2010/8/31 EG-3870UTK A110213 2010/11/16 EG-3870UTK A110214 2010/10/12 EG-3870UTK A110215 2010/10/1 EG-3870UTK A110216 2010/10/1 EG-3870UTK A110217 2010/10/12 EG-3870UTK A110218 2010/10/13 EG-3870UTK A110219 2010/10/18 EG-3870UTK A110221 2010/10/22 EG-3870UTK A110222 2010/11/17 EG-3870UTK A110224 2010/11/22 EG-3870UTK A110225 2010/12/27 EG-3870UTK A110226 2010/11/29 EG-3870UTK A110227 2010/12/27 EG-3870UTK A110228 2010/12/15 EG-3870UTK A110229 2010/12/16 EG-3870UTK A110230 2011/1/21 EG-3870UTK A110231 2011/1/21 EG-3870UTK A110232 2011/1/28 EG-3870UTK A110233 2011/1/28 EG-3870UTK A110234 2011/2/4 EG-3870UTK A110235 2011/4/4 EG-3870UTK A110236 2011/2/16 EG-3870UTK A110237 2011/2/15 EG-3870UTK A110239 2011/4/4 EG-3870UTK A110240 2011/4/11 EG-3870UTK A110241 2011/5/12 EG-3870UTK A110242 2011/5/19 EG-3870UTK A110243 2011/5/19 EG-3870UTK A110244 2011/5/26 EG-3870UTK A110245 2011/5/24 EG-3870UTK A110249 2011/6/8 EG-3870UTK A110250 2011/6/8 EG-3870UTK A110253 2011/6/29 EG-3870UTK A110254 2011/6/14 EG-3870UTK A110255 2011/6/15 EG-3870UTK A110256 2011/6/29 EG-3870UTK A110257 2011/6/29 EG-3870UTK A110258 2011/6/29
• Recalling Firm/ Manufacturer: Pentax Medical Company; 102 Chestnut Ridge Rd; Montvale NJ 07645
• For Additional Information Contact: Mr. Paul Silva; 201-571-2300
• Manufacturer Reason for Recall: Endoscope ultrasound balloon evacuation tube may become clogged with patient body fluid if users fail to properly follow instructions for pre-procedure check, operating the suction valve during procedure and pre-cleaning procedure.
• FDA Determined Cause: Equipment maintenance
• Action: Pentax sent an "URGENT MEDICAL DEVICE RECALL" letter on March 14, 2012 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. A response form was included for customers to complete and return to the firm. Contact the firm at 800-431-5880 ext. 2064 for questions regarding this notice.
• Quantity in Commerce: 194 units
• Distribution: Nationwide Distribution.
• 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 = ITX