Olympus Corporation of the Americas: Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

Hazard

There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).

Details from the source

Reason for recall: There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP). Distribution: US Nationwide. Quantity: 279 units Lot/code info: UDI-DI: 04042761087698; Serial Numbers: 101698 102191 102706 103016 103068 103112 103161 103199 101702 102195 102707 103018 103069 103114 103162 103200 101920 102197 102709 103019 103072 103115 103163 103201 101923 102266 102710 103020 103073 103116 103165 103203 101925 102427 102711 103025 103074 103117 103166 103206 101929 102660 102712 103026 103075 103119 103167 103207 101932 102661 102713 103029 103076 103120 103168 103208 101933 102664 102714 103030 103077 103121 103169 103209 101934 102665 102715 103031 103078 103122 103170 103210 101937 102668 102716 103033 103080 103123 103172 103211 101945 102672 102717 103034 103081 103124 103173 103212 101947 102673 102718 103035 103082 103125 103174 103214 102149 102674 102719 103037 103083 103126 103176 103215 102150 102678 102721 103041 103084 103127 103177 103216 102153 102679 102722 103042 103085 103132 103178 103217 102154 102681 102723 103043 103087 103133 103179 103218 102155 102682 102724 103044 103088 103134 103180 103219 102156 102683 102993 103045 103089 103135 103181 103220 102159 102684 102994 103046 103091 103136 103182 103221 102161 102685 102995 103047 103092 103137 103183 103222 102162 102686 102996 103048 103094 103139 103184 103223 102163 102687 102997 103049 103095 103140 103185 103224 102164 102688 102998 103050 103096 103141 103186 103225 102167 102689 102999 103051 103097 103142 103187 103228 102168 102691 103000 103052 103098 103143 103188 103583 102172 102692 103001 103053 103099 103144 103189 103584 1021

UPC codes

04042761087698

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.