Generic Name: Therapeutic Electrosurgical Unit — Trade Name: High-frequency Surgical Unit Esg-410

Recalling firm: Name of Manufacturer and Distributor: Olympus Medical Systems Corporation, Hachioji Office — Address of Manufacturer and Distributor: 2951 Ishikawa-cho, Hachioji City, Tokyo — Type of License:...
Product: Lot: 製造番号： 101026 101027 101065 101108 101112 101132 101133 101134 101135 101136 101149 101150 101151 101152 101153 101154 101155 101156 101157 101158 101159 101160 101161 101162 101163 101165 101166 101167 101188 101189 101190 101191 101192 101193 101194 101195 101196 101197 101198 101199 101200 101201 101202 101203 101204 101205 101206 101207 101208 101209 101211 101212 101213 101214 101215 101216 101217 101219 101221 101222 101527 101528 101530 101534 101535 101536 101537 101538 101542 101543 101545 101546 101547 101549 101569 101570 101571 101572 101573 101574 101575 101576 101577...
Reason: We have received reports that the error message "E0662 (System Error)" appears on the affected product, causing the unit to restart once or repeatedly. Our investigation has determined that this issue is caused by a change in an electronic component. Since this change may cause the CQM (Contact Quality Monitor) circuit to malfunction, leading to the occurrence of this issue, we are conducting a voluntary recall.
Classification: Class II
Category: medical device recall
Country: Japan
Agency: PMDA-DEVICE
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/e0d7c91e-8439-4a16-a9f5-ddc2ef93f611