Device Recall EG3870UTK, Pentax Ultrasound Video Gastroscope

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

Radiology Devices

2

No

Nationwide Distribution.

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.