PlainRecordsFDA · Medical device recall
GE Datex-Ohmeda Aisys Anesthesia System… and 2 more products
- Date posted by the FDA
- Oct. 6, 2010
- Status
- Terminated
- Filed by
- GE Healthcare, LLC
- Reason
- Users may inadvertently leave a test plug in the inspiratory flow sensor after completing Low P Leak Check on the SCGO (Switched Common Gas Outlet) configuration of Avance, Amingo, and Aisys anesthesia machines that may impact patient safety. If the test plug remains in place and therapy is initiated, the machine will not provide gas to the patient. This would inhibit mechanical or manual ventila
- Distribution pattern
- Worldwide Distribution: USA: All States, including DC, except Delaware, and the countries of YEMEN, VIETNAM, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SYRIA, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI, ARABIA, RUSSIA, PORTUGAL POLAND, PERU, PANAMA, NORWAY, NETHERLAND, MACEDONIA, LITHUANIA, LEBANON, LATVIA, KUWAIT, KOREA, KENYA, JORDAN, JAPAN, ITALY, IRELAND, INDIA, HUNGARIA, HONG KONG, HONDURAS, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CZECH REPUBLIC, CROATIA, COLOMBIA, CHINA, CHILE, CANADA, BULGARIA, BRAZIL, BERMUDA, BELGIUM, AUSTRIA, AUSTRALIA, and ARGENTINA.
3 products in this recall
GE Datex-Ohmeda Aisys Anesthesia System…
- Product
- GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
- Quantity
- 3039
- Codes and lots
- ANAH00114 ANAH00115 ANAH00116 ANAH00117 ANAH00119 ANAH00120 ANAH00121 ANAH00122 ANAH00123 ANAH00124 ANAH00125 ANAH00126 ANAJ00100 ANAJ00101 ANAJ00102 ANAJ00103 ANAJ00104 ANAJ00106 ANAJ00107 ANAJ00108 ANAJ00109 ANAJ00110 ANAJ00111 ANAJ00112 ANAJ00113 ANAJ00114 ANAJ00115 ANAJ00116 ANAJ00119 ANAJ00120 ANAJ00121 ANAJ00122 ANAJ00123 ANAJ00124 ANAJ00125 ANAJ00126 ANAJ00127 ANAJ00128 ANAJ00129 ANAJ00131 ANAJ00132 ANAJ00133 ANAJ00134 ANAJ00135 ANAJ00136 ANAJ00137 ANAJ00141 ANAJ00142 ANAJ00143 ANAJ00145 ANAJ00146 ANAJ00147 ANAJ00164 ANAJ00165 ANAJ00166 ANAJ00167 ANAJ00168 ANAJ00169 ANAJ00170 ANAJ00171 ANAJ00172 ANAJ00173 ANAJ00174 ANAJ00175 ANAJ00176 ANAJ00177 ANAJ00178 ANAJ00179 ANAJ00180 ANAJ00181 ANAJ00182 ANAJ00183 ANAJ00184 ANAJ00185 ANAJ00186 ANAJ00187 ANAJ00188 ANAJ00189 ANAJ00190 ANAJ00191 ANAJ00194 ANAJ00195 ANAJ00196 ANAJ00197 ANAJ00198 ANAJ00199 ANAJ00200 ANAJ00201 ANAJ00202 ANAJ00203 ANAJ00204 ANAJ00205 ANAJ00206 ANAJ00207 ANAJ00208 ANAJ00209 ANAJ00210 ANAJ00211 ANAJ00212 ANAJ00213 ANAJ00214 ANAJ00215 ANAJ00216 ANAJ00217 ANAJ00218 ANAJ00219 ANAJ00220 ANAJ00221 ANAJ00222 ANAJ00223 ANAJ00224 ANAJ00225 ANAJ00226 ANAJ00227 ANAJ00228 ANAJ00229 ANAJ00230 ANAJ00231 ANAJ00232 ANAJ00233 ANAJ00234 ANAJ00235 ANAJ00236 ANAJ00237 ANAJ00238 ANAJ00239 ANAJ00240 ANAJ00241 ANAJ00242 ANAJ00243 ANAJ00244 ANAJ00245 ANAJ00246 ANAJ00247 ANAJ00248 ANAJ00249 ANAJ00250 ANAJ00251 ANAJ00252 ANAJ00253 ANAJ00254 ANAJ00255 ANAJ00256 ANAJ00257 ANAJ00258 ANAJ00259 ANAJ00260 ANAJ00261 ANAJ00264 ANAJ00265 ANAJ00266 ANAJ00267 ANAK00100 ANAK00101 ANAK00102 ANAK00103 ANAK00104 ANAK00105 ANAK00106 ANAK00109 ANAK00110 ANAK00111 ANAK00112 ANAK00113 ANAK00114 ANAK00115 ANAK00116 ANAK00117 ANAK00118 ANAK00119 ANAK00120 ANAK00121 ANAK00123 ANAK00124 ANAK00125 ANAK00126 ANAK00127 ANAK00128 ANAK00129 ANAK00130 ANAK00131 ANAK00132 ANAK00133 ANAK00134 ANAK00135 ANAK00136 ANAK00137 ANAK00138 ANAK00139 ANAK00140 ANAK00142 ANAK00143 ANAK00144 ANAK00145 ANAK00156 ANAK00157 ANAK00158 ANAK00159 ANAK00160 ANAK00162 ANAK00163 ANAK00164 ANAK00165 ANAK00166 ANAK00167 ANAK00168 ANAK00169 ANAK00170 ANAK00171 ANAK00172 ANAK00173 ANAK00174 ANAK00175 ANAK00176 ANAK00177 ANAK00178 ANAK00179 ANAK00180 ANAK00181 ANAK00182 ANAK00183 ANAK00184 ANAK00185 ANAK00186 ANAK00187 ANAK00188 ANAK00189 ANAK00190 ANAK00191 ANAK00192 ANAK00193 ANAK00194 ANAK00195 ANAK00196 ANAK00197 ANAK00198 ANAK00199 ANAK00200 ANAK00201 ANAK00202 ANAK00203 ANAK00207 ANAK00213 ANAK00214 ANAK00215 ANAK00223 ANAK00224 ANAK00225 ANAK00226 ANAK00227 ANAK00228 ANAK00229 ANAK00230 ANAK00231 ANAK00232 ANAK00233 ANAK00236 ANAK00238 ANAK00239 ANAK00241 ANAK00242 ANAK00247 ANAK00248 ANAK00249 ANAK00250 ANAK00254 ANAK00255 ANAK00256 ANAK00257 ANAK00258 ANAK00259 ANAK00260 ANAK00261 ANAK00262 ANAK00263 ANAK00264 ANAK00265 ANAK00266 ANAK00268 ANAK00269 ANAK00270 ANAK00271 ANAK00272 ANAK00273 ANAK00273- ANAK00274 ANAK00275 ANAK00276 ANAK00277 ANAK00278 ANAK00279 ANAK00280 ANAK00284 ANAK00285 ANAK00286 ANAK00287 ANAK00288 ANAK00289 ANAK00290…
- Recall started
- Aug. 30, 2010
- Device type
- Gas-Machine, Anesthesia
- Root cause (FDA)
- Employee error
- What the company told customers
- GE Healthcare issued an " Urgent Medical Device Correction" letter dated August 30, 2010 to consignees. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager and Director of Biomedical/ Clinical Engineering. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Instructions. Customers were instructed to: 1. Ensure the plug is removed at the completion of the Low P Leak check. 2. Review the Preoperative Checkout procedure listed in section 4 of the User Reference Manual with appropriate personnel. Ensure that the Preoperative Checkout procedure is completed in its entirety prior to each case, or as required. All facilities will be contacted by their local GE GE Field Technical Service Team to schedule installation of a software update and a revised test plug for your machines configured with SCGO. Customers are to contact their local GE Healthcare Customer or Technical Support Representative if they need additional information.
- Recall number
- Z-0008-2011
GE Datex-Ohmeda Avance Anesthesia System…
- Product
- GE Datex-Ohmeda Avance Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
- Quantity
- 4541
- Codes and lots
- ANBG00100 ANBG00101 ANBG00102 ANBG00103 ANBG00104 ANBG00105 ANBG00106 ANBG00107 ANBG00108 ANBG00109 ANBG00110 ANBG00111 ANBG00112 ANBG00113 ANBG00114 ANBG00115 ANBG00116 ANBG00117 ANBG00119 ANBG00120 ANBG00122 ANBG00123 ANBG00124 ANBG00125 ANBG00126 ANBG00127 ANBG00128 ANBG00129 ANBG00130 ANBG00131 ANBG00132 ANBG00133 ANBG00134 ANBG00135 ANBG00136 ANBG00137 ANBG00138 ANBG00139 ANBG00140 ANBG00141 ANBG00142 ANBG00143 ANBG00144 ANBG00145 ANBG00146 ANBG00147 ANBG00148 ANBG00149 ANBG00150 ANBG00151 ANBG00152 ANBG00153 ANBG00154 ANBG00155 ANBG00156 ANBG00157 ANBG00158 ANBG00160 ANBG00161 ANBG00162 ANBG00163 ANBG00164 ANBG00165 ANBG00166 ANBG00167 ANBG00168 ANBG00169 ANBG00170 ANBG00171 ANBG00172 ANBG00173 ANBG00174 ANBG00175 ANBG00176 ANBG00177 ANBG00178 ANBG00179 ANBG00180 ANBG00181 ANBG00182 ANBG00183 ANBG00184 ANBG00185 ANBG00186 ANBG00187 ANBG00188 ANBG00189 ANBG00190 ANBG00191 ANBG00192 ANBG00193 ANBG00194 ANBG00195 ANBG00196 ANBG00197 ANBG00198 ANBG00199 ANBG00200 ANBG00201 ANBG00202 ANBG00203 ANBG00204 ANBG00205 ANBG00206 ANBG00207 ANBG00208 ANBG00209 ANBG00210 ANBG00211 ANBG00212 ANBG00213 ANBG00214 ANBG00215 ANBG00216 ANBG00217 ANBG00218 ANBG00219 ANBG00220 ANBG00221 ANBG00222 ANBG00223 ANBG00224 ANBG00225 ANBG00226 ANBG00227 ANBG00228 ANBG00229 ANBG00230 ANBG00231 ANBG00232 ANBG00233 ANBG00234 ANBG00235 ANBG00236 ANBG00237 ANBG00238 ANBG00239 ANBG00240 ANBG00241 ANBG00242 ANBG00243 ANBG00244 ANBG00245 ANBG00246 ANBG00247 ANBG00248 ANBG00249 ANBG00250 ANBG00251 ANBG00252 ANBG00253 ANBG00254 ANBG00255 ANBG00256 ANBG00257 ANBG00258 ANBG00259 ANBG00260 ANBG00261 ANBG00262 ANBG00263 ANBG00264 ANBG00265 ANBG00266 ANBG00267 ANBG00268 ANBG00269 ANBG00270 ANBG00271 ANBG00272 ANBG00273 ANBG00274 ANBG00275 ANBG00276 ANBG00277 ANBG00278 ANBG00279 ANBG00280 ANBG00281 ANBG00282 ANBG00286 ANBG00287 ANBG00288 ANBG00289 ANBG00290 ANBG00291 ANBG00292 ANBG00293 ANBG00294 ANBG00295 ANBG00296 ANBG00297 ANBG00298 ANBG00299 ANBG00300 ANBG00301 ANBG00302 ANBG00303 ANBG00304 ANBG00305 ANBG00306 ANBG00307 ANBG00308 ANBG00309 ANBG00310 ANBG00311 ANBG00312 ANBG00313 ANBG00314 ANBG00315 ANBG00316 ANBG00317 ANBG00318 ANBG00319 ANBG00320 ANBG00321 ANBG00322 ANBG00323 ANBG00324 ANBG00325 ANBG00326 ANBG00327 ANBG00328 ANBG00329 ANBG00330 ANBG00331 ANBG00332 ANBG00334 ANBG00336 ANBG00337 ANBG00338 ANBG00339 ANBG00340 ANBG00341 ANBG00342 ANBG00343 ANBG00344 ANBG00345 ANBG00346 ANBG00347 ANBG00348 ANBG00349 ANBG00350 ANBG00351 ANBG00352 ANBG00353 ANBG00354 ANBG00355 ANBG00356 ANBG00357 ANBG00358 ANBG00359 ANBG00360 ANBG00361 ANBG00362 ANBG00364 ANBG00365 ANBG00366 ANBG00367 ANBG00368 ANBG00369 ANBG00370 ANBG00371 ANBG00372 ANBG00373 ANBG00377 ANBG00378 ANBG00379 ANBG00380 ANBG0172 ANBH00100 ANBH00101 ANBH00102 ANBH00103 ANBH00104 ANBH00105 ANBH00106 ANBH00107 ANBH00108 ANBH00109 ANBH00110 ANBH00111 ANBH00112 ANBH00113 ANBH00114 ANBH00115 ANBH00116 ANBH00117 ANBH00118 ANBH00119 ANBH00120 ANBH00121 ANBH00122 ANBH00123 ANBH00124 ANBH00125 ANBH00126 ANBH00127 ANBH00128 ANBH00129…
- Recall started
- Aug. 30, 2010
- Device type
- Gas-Machine, Anesthesia
- Root cause (FDA)
- Employee error
- What the company told customers
- GE Healthcare issued an " Urgent Medical Device Correction" letter dated August 30, 2010 to consignees. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager and Director of Biomedical/ Clinical Engineering. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Instructions. Customers were instructed to: 1. Ensure the plug is removed at the completion of the Low P Leak check. 2. Review the Preoperative Checkout procedure listed in section 4 of the User Reference Manual with appropriate personnel. Ensure that the Preoperative Checkout procedure is completed in its entirety prior to each case, or as required. All facilities will be contacted by their local GE GE Field Technical Service Team to schedule installation of a software update and a revised test plug for your machines configured with SCGO. Customers are to contact their local GE Healthcare Customer or Technical Support Representative if they need additional information.
- Recall number
- Z-0009-2011
GE Datex-Ohmeda Amingo Anesthesia System…
- Product
- GE Datex-Ohmeda Amingo Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
- Quantity
- 131
- Codes and lots
- AMNM00101 AMNM00102 AMNM00103 AMNM00104 AMNM00105 AMNM00106 AMNM00107 AMNM00108 AMNM00109 AMNM00110 AMNM00111 AMNM00112 AMNM00113 AMNM00114 AMNM00115 AMNM00116 AMNM00117 AMNM00118 AMNM00119 AMNM00120 AMNM00121 AMNM00122 AMNM00123 AMNM00124 AMNM00125 AMNM00126 AMNM00127 AMNM00128 AMNM00129 AMNM00130 AMNM00131 AMNM00132 AMNM00133 AMNM00134 AMNM00135 AMNM00136 AMNM00137 AMNM00138 AMNM00139 AMNM00140 AMNM00141 AMNM00142 AMNM00143 AMNM00144 AMNM00145 AMNM00146 AMNM00147 AMNM00148 AMNM00149 AMNM00150 AMNM00151 AMNM00152 AMNM00153 AMNM00154 AMNM00155 AMNM00156 AMNN00100 AMNN00101 AMNN00102 AMNN00103 AMNN00104 AMNN00105 AMNN00106 AMNN00107 AMNN00108 AMNN00109 AMNN00110 AMNN00111 AMNN00112 AMNN00113 AMNN00114 AMNN00115 AMNN00116 AMNN00117 AMNN00118 AMNN00119 AMNN00120 AMNN00121 AMNN00122 AMNN00123 AMNN00124 AMNN00125 AMNN00126 AMNN00127 AMNN00128 AMNN00129 AMNN00130 AMNN00131 AMNN00132 AMNN00133 AMNN00134 AMNN00135 AMNN00136 AMNN00137 AMNN00138 AMNN00139 AMNN00140 AMNN00141 AMNN00142 AMNN00143 AMNN00144 AMNN00145 AMNN00146 AMNN00147 AMNN00148 AMNN00149 AMNN00150 AMNN00151 AMNN00152 AMNN00156 AMNN00157 AMNN00158 AMNN00159 AMNN00160 AMNN00161 AMNN00162 AMNN00163 AMNN00164 AMNP00100 AMNP00101 AMNP00102 AMNP00103 AMNP00104 AMNP00105 AMNP00106 AMNP00107 AMNP00108 AMNP00109 AMNP00110 AMNP00111 AMNP00112
- Recall started
- Aug. 30, 2010
- Device type
- Gas-Machine, Anesthesia
- Root cause (FDA)
- Employee error
- What the company told customers
- GE Healthcare issued an " Urgent Medical Device Correction" letter dated August 30, 2010 to consignees. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager and Director of Biomedical/ Clinical Engineering. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Instructions. Customers were instructed to: 1. Ensure the plug is removed at the completion of the Low P Leak check. 2. Review the Preoperative Checkout procedure listed in section 4 of the User Reference Manual with appropriate personnel. Ensure that the Preoperative Checkout procedure is completed in its entirety prior to each case, or as required. All facilities will be contacted by their local GE GE Field Technical Service Team to schedule installation of a software update and a revised test plug for your machines configured with SCGO. Customers are to contact their local GE Healthcare Customer or Technical Support Representative if they need additional information.
- Recall number
- Z-0010-2011
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0008-2011, Z-0009-2011, Z-0010-2011. The agency record governs; check it and the company before acting.