Events

Recall of Device Recall EG3870UTK, Pentax Ultrasound Video Gastroscope

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pentax Medical Company.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61613
  • Event Risk Class
    Class 2
  • Event Number
    Z-1489-2012
  • Event Initiated Date
    2012-03-14
  • Event Date Posted
    2012-05-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108539
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Transducer, ultrasonic, diagnostic - Product Code ITX
  • Reason
    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.
  • 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.

Device

Device Recall EG3870UTK, Pentax Ultrasound Video Gastroscope
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    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.
  • Manufacturer
    Pentax Medical Company

Manufacturer

Pentax Medical Company
  • Manufacturer Address
    Pentax Medical Company, 102 Chestnut Ridge Rd, Montvale NJ 07645
  • Manufacturer Parent Company (2017)
    HOYA Corp.
  • Source
    USFDA