FDA Device recall Z-2116-2014
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fib…
- FDA Device
- Class II
- terminated
- Published 2014-07-30
On 2014-07-30 the FDA classified a Class II recall of EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fib… by Pentax Medical, citing aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope. This may result in patient injury if….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2116-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-12 |
| Published | 2014-07-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Pentax Medical |
| Distribution | US |
Product
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
Reason
Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope. This may result in patient injury if the Instruction for Use is not followed carefully by the user.
Identifiers
| code_info | Model: EG-3630U A01013 E010080 E110111 E110159 E110236 A01017 E010082 E110116 E110161 E110237 A01022 E010084 E1101…Model: EG-3630U A01013 E010080 E110111 E110159 E110236 A01017 E010082 E110116 E110161 E110237 A01022 E010084 E110118 E110167 E110239 A01025 E010092 E110120 E110169 E110240 A01026 E010093 E110132 E110172 E110256 A01028 E010094 E110134 E110177 E110277 A01029 E010095 E110135 E110179 E110278 A01031 E010096 E110138 E110182 E110282 A01033 E01037 E110139 E110187 E110283 A01036 E01038 E110140 E110188 E110285 E010064 E01039 E110141 E110193 E110287 E010066 E01042 E110144 E110195 E110289 E010069 E01043 E110145 E110202 E110290 E010070 E01046 E110146 E110205 E110306 E010075 E01054 E110147 E110208 E110307 E010077 E01061 E110156 E110210 E110308 E010078 E01062 E110157 E110219 Model: EG-3830UT E110067 E110160 E110204 E110275 E110374 E110070 E110163 E110206 E110277 E110377 E110074 E110165 E110212 E110286 E110379 E110079 E110168 E110214 E110289 E110426 E110082 E110171 E110224 E110292 E110428 E110093 E110172 E110228 E110295 E110433 E110095 E110174 E110230 E110309 E110439 E1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2116-2014%22
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