GE Healthcare, LLC Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243 g) 1006-9310-000-017602 h) 1006-9310-000-103785 I) 1006-9310-000-025109 j) 1006-9310-000-009650 k) 1006-9310-000-015224 l) 1006-9310-000-031881 m) 1006-9310-000-031854 n) 1006-9310-000-026571 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243 g) 1006-9310-000-017602 h) 1006-9310-000-103785 I) 1006-9310-000-025109 j) 1006-9310-000-009650 k) 1006-9310-000-015224 l) 1006-9310-000-031881 m) 1006-9310-000-031854 n) 1006-9310-000-026571
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
a) 1006-9310-000 Lot/Serial Numbers: AMTE00190 AMTH00218 AMTE00125 AMTE00126 AMTE00118 AMTG00102 AMTF00224 AMTG00108 b) 1006-9110-000 Lot/Serial Numbers: AMTG00211 AMTG00149 AMTF00152 AMTH00115 AMTH00172 AMTH00108 AMTF00127 AMTH00125 AMTF00128 AMTF00189 AMTH00100 AMTG00111 AMTH00210 AMTG00178 AMTG00199 AMTF00126 AMTF00153 AMTG00113 AMTH00134 AMTF00168 AMTH00114 AMTG00177 AMTF00211 AMTF00166 AMTF00197 AMTF00143 AMTG00156 AMTG00115 AMTE00221 AMTF00125 AMTG00146 AMTG00167 AMTG00179 AMTG00190 AMTH00193 AMTH00194 AMTF00167 AMTF00141 AMTH00116 AMTG00169 AMTG00159 AMTG00212 AMTG00213 AMTF00144 AMTG00112 AMTH00126 AMTG00166 AMTG00155 AMTF00165 AMTE00222 AMTF00210 AMTE00225 AMTG00197 AMTG00148 AMTH00118 AMTH00133 AMTF00142 AMTF00129 AMTH00190 AMTE00227 AMTG00147 AMTG00201 AMTG00175 AMTF00169 AMTF00212 AMTG00165 AMTF00154 AMTG00145 AMTF00203 AMTH00119 AMTF00151 AMTH00117 AMTG00168 AMTG00176 AMTF00150 AMTF00209 AMTH00186 AMTF00140 AMTF00108 AMTE00223 AMTH00132 AMTG00158 AMTH00107 AMTF00183 AMTG00114 AMTG00200 AMTG00198 c) 1006-9023-000 Lot/Serial Numbers: AMTE00239 AMTF00120 AMTE00155 AMTH00183 AMTH00144 AMTF00123 AMTF00190 AMTE00158 AMTG00136 AMTD00108 AMTD00105 AMTF00121 AMTD00122 AMTE00220 AMTE00159 AMTG00138 AMTE00157 AMTE00156 AMTF00122 AMTF00124 AMTG00137 AMTD00110 AMTF00192 AMTD00109 d) 1006-9028-000 Lot/Serial Numbers: AMTF00170 e) 1006-9310-000-305077 Lot/Serial Numbers: AMTT00236 f) 1006-9310-000-015243 Lot/Serial Numbers: AMTL00106 g) 1006-9310-000-017602 Lot/Serial Numbers: AMTR00110 AMTL00285 AMTP00299 AMTL00194 h) 1006-9310-000-103785 Lot/Serial Numbers: AMTR00120 I) 1006-9310-000-025109 Lot/Serial Numbers: AMTM00216 AMTM00196 j) 1006-9310-000-009650 Lot/Serial Numbers: AMTK00152 k) 1006-9310-000-015224 Lot/Serial Numbers: AMTL00102 l) 1006-9310-000-031881 Lot/Serial Numbers: AMTN00100 AMTN00101 m) 1006-9310-000-031854 Lot/Serial Numbers: AMTN00211 n) 1006-9310-000-026571 Lot/Serial Numbers:
GE Healthcare, LLC is recalling Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 due to Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insuff. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may provide an opportunity for a malicious actor that has already penetrated the hospital network to send fraudulent flow sensor correction parameters.
Recommended Action
Per FDA guidance
The firm sent an urgent medical device correction notice to their consignees by letter on 07/19/2019. The letter explained the issue and requested that the consignee ensure that the devices are connected to a sufficiently secure terminal server.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026