FDA Device recall Z-0114-2020
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) 1006-9310-000-01…
- FDA Device
- Class II
- terminated
- Published 2019-12-25
On 2019-12-25 the FDA classified a Class II recall of 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) 1006-9310-000-01… by Ge Healthcare, citing 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 serv….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0114-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-19 |
| Published | 2019-12-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | n/a |
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
Reason
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.
Identifiers
| code_info | a) 1006-9310-000 Lot/Serial Numbers: AMTE00190 AMTH00218 AMTE00125 AMTE00126 AMTE00118 AMTG00102 AMTF00224 A…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 AMT |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0114-2020%22
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