FDA Device recall Z-0115-2020
Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d) 1006-9112-000 e) 1006-9113-000 f) 1006-9020-000 g) 1006-…
- FDA Device
- Class II
- terminated
- Published 2019-12-25
On 2019-12-25 the FDA classified a Class II recall of Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d) 1006-9112-000 e) 1006-9113-000 f) 1006-9020-000 g) 1006-… 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-0115-2020 |
| 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 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d) 1006-9112-000 e) 1006-9113-000 f) 1006-9020-000 g) 1006-9033-000 h) 1006-9117-000 i) 1006-9119-000 j) 1006-9030-000 k) 1006-9032-000 l) 1006-9022-000 m) To be provided n) 1006-9120-000 o) 1006-9027-000 p) 1006-9003-000 q) 1006-9025-000
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) 1006-9300-000 Lot/Serial Numbers: AMRB00497 b) 1006-9305-000 Lot/Serial Numbers: AMRE01294 AMRF01283 A…a) 1006-9300-000 Lot/Serial Numbers: AMRB00497 b) 1006-9305-000 Lot/Serial Numbers: AMRE01294 AMRF01283 AMRG01624 AMRG01625 AMRF02527 AMRF02529 AMRF02532 AMRF02534 AMRE02800 AMRE00725 AMRE01720 AMRF02386 AMRF02398 AMRF02399 AMRF02400 AMRF02401 AMRF02402 AMRF02403 AMRG02367 AMRG02368 AMRG02369 AMRG02370 AMRH00168 AMRE01962 AMRE01297 AMRE01298 AMRE01299 AMRE01300 AMRE01301 AMRE01302 AMRE01303 AMRE02061 AMRE02065 AMRE02124 AMRE01395 AMRF02556 AMRG02955 AMRG02958 AMRG03077 AMRG03179 AMRE00891 AMRE00892 AMRE00893 AMRE00894 AMRE01178 AMRE01179 AMRE01182 AMRE01183 AMRE01184 AMRE01185 AMRE01186 AMRE01187 AMRE01188 AMRE01191 AMRE01192 AMRE01193 AMRE01195 AMRE01719 AMRG00316 AMRF03164 AMRF03165 AMRF03166 AMRF03167 AMRF03168 AMRF03169 AMRF03170 AMRE01930 AMRE02795 AMRG00695 AMRG00696 AMRG00697 AMRE00911 AMRE00912 AMRF02650 AMRF02651 AMRF02652 AMRF02653 AMRE01465 AMRE01466 AMRE01659 AMRE01660 AMRE01664 AM |
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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-0115-2020%22
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