Aestiva 7900
Medical device recall Z-0115-2020. Published in FDA’s Enforcement Report on Dec 25, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 25, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 7168 devices how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
7168 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,994 characters
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 AMRE01268 AMRE01336 AMRE01337 AMRE01338 AMRE02143 AMRE02648 AMRF01160 AMRF01211 AMRF01212 AMRF01213 AMRF01214 AMRF01215 AMRF02143 AMRF03161 AMRG00605 AMRG00606 AMRG00607 AMRG00608 AMRH00589 AMRH00591 AMRH00594 AMRF01298 AMRG01091 AMRG01092 AMRG01093 AMRG01094 AMRG01095 AMRG01096 AMRG01097 AMRG01098 AMRG01099 AMRG01100 AMRG01101 AMRG01102 AMRF01489 AMRE02796 AMRE02797 AMRF00684 AMRG01162 AMRF00355 AMRF00356 AMRF00357 AMRF00358 AMRF00359 AMRF00545 AMRF00548 AMRF00551 AMRF00829 AMRF00830 AMRF00831 AMRE00128 AMRF00924 AMRG01269 AMRG01249 AMRG01250 AMRG01837 AMRF00360 AMRE02935 AMRF02147 AMRE01806 AMRE01811 AMRE01812 AMRE01392 AMRE02339 AMRF01819 AMRF01322 AMRF01323 AMRF03137 AMRF03138 AMRG02943 AMRG02954 AMRE01393 AMRE01687 AMRE02687 AMRE02023 AMRE00707 AMRE00718 AMRE00719 AMRF01964 AMRF01965 AMRF01966 AMRF01967 AMRF01968 AMRG01640 AMRF00630 AMRF02893 AMRF02894 AMRG00971 AMRG00972 AMRG00973 AMRG00974 AMRE01048 AMRE01107 AMRE01259 AMRE01262 AMRE01263 AMRE02517 AMRE03018 AMRE03019 AMRE03020 AMRF00176 AMRF00177 AMRF00433 AMRF00434 AMRF00680 AMRF00681 AMRF01613 AMRF01816 AMRF01818…
FDA’s list runs to 109,438 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 19, 2019.
- FDA classified it on Dec 17, 2019.
- FDA’s Enforcement Report published it on Dec 25, 2019.
- FDA terminated it on Apr 13, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 109,438 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.