FDAFDA · Alimentos y medicamentos·N.º oficial Z-1150-2013
EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
Publicado el 24 de abril de 2013 · Inicio del retiro: 28 de marzo de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because they have received reports of smoke emanating from the system due to a circuit board malfunction that may occur in the Channel Control Manifold sub-assembly.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Advanced Sterilization Products
- Distribuidor
- Nationwide Distribution
- Lote
- Batch Numbers: 5041090177 5041090127 5041090131 5041110307 5041120049 5041120065 5041120076 5041100256 5041110157 5041120133 5040107029 5041110264 5041110265 5041110280 5041100218 5041100219 5041110018 5041110143 5041110079 5041110329 5041110212 5041120155 5041100250 5041110080 5041110174 5041110330 5041110203 5041090103 5041090110 5041100103 5041100104 5041100142 5041090184 5041090185 5041120120 5041120070 5041120073 5041120080 5040107087 5041110158 5041100189 5041100186 5041110189 5041080029 5041080063 5041120034 5041080028 5041080060 5041080064 5041100145 5041100146 5041100151 5041100268 5041120081 5040107065 5041120087 5041120116 5041110111 5041110113 5040107115 5041070037 5041110121 5041110140 5041090067 5041090167 5041090168 5041120154 5041090179 5041110177 5041110112 5041110129 5041110130 5041090069 5041110271 5041070036 5041070044 5041070045 5041090034 5041090054 5041090147 5041100192 5041090203 5041100214 5041100265 5041110186 5041110187 5041100067 5041100071 5041100079 5041110075 5041110078 5041120111 5041100136 5041100164 5041100043 5041100046 5041100047 5041110191 5041100262 5041110155 5041110154 5041110327 5041090128 5041110185 5041120060 5041120108 5041110316 5041110231 5041110246 5041090146 5041110291 5041120203 5041090061 5041090063 5041100068 5041100076 5041100222 5041090205 5041090097 5041090141 5041110182 5041090145 5041090129 5041100257 5041120149 5041120152 5041110127 5041130007 5041130008 5041120137 5041110176 5041110188 5041110183 5041100126 5041100127 5041100156 5041070042 5041080077 5041090108 5041100197 5041110120 5041100162 5041090194 5041110131 5041110142 5041110147 5041120094 5041080071 5041080062 5041090175 5041110172 5041110173 5041120071 5041090182 5041100036 5040107105 5041100248 5041100251 5041120150 5041090090 5041090092 5041100077 5041100081 5041100089 5041100259 5041100167 5041100020 5041100025 5041100220 5041120036 5041100205 5041100211 5041110213 5041120179 5041120185 5041110283 5041110315 5041100233 5041100107 5041100108 5041100116 5041100117 5041110228 5041110247 5041110257 5041110333 5041110238 5041110229 5041100022 5041100017 5041110108 5041100241 5041100232 5041100242 5041110322 5041090015 5041090170 5041100041 5041100010 5041100011 5041120099 5041100038 5041100202 5041110115 5041090112 5041100264 5041090086 5041120124 5041100124 5041100129 5041100266 5041100267 5041120143 5041120202 5041090137 5041090164 5041100102 5041100132 5041120129 5041120132 5041120096 5041090031 5041090169 5041090057 5041090060 5041090101 5041100004 5041090093 5041090099 5041110073 5041120190 5041110239 5041090180 5041120209 5041110161 5041110162 5041090134 5041120172 5041100062 5041110092 5041120023 5041120097 5041110274 5041120088 5041090104 5041090113 5041120174 5041100019 5041110088 5041110106 5041110318 5041100115 5041090087 5041110039 5041100015 5041090161 5041100225 5041110332 5041100002 5041100003 5041120146 5041120114 5041100223 5041110116 5041120199 5041120091 5041110326 5041080070 5040107114 5041080076 5041090091 5041120004 5041100096 5041110263 5041110262 5041110242 5041110255 5041110259 5041120068 5041110205 5041120035 5041080058 5041110219 5041100182 5041090198 5041120213 5041120101 5041100183 5041100074 5041110016 5041110254 5041080078 5041090139 5041120112 5041100048 5041120208 5041090144 5041090140 5041090193 5041100007 5041100128 5041100138 5041100188 5041110284 5041120107 5041120131 5041120169 5041120178 5041120184 5041100180 5041120206 5041110006 5041110012 5041130010 5041130011 5041100080 5041110098 5041110100 5041120103 5041120141 5041080057 5041080065 5041080066 5041080072 5041090098 5041090100 5041090221 5041100024 5041100034 5041100092 5041100023 50411000
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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