Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e)…
Medical device recall Z-0114-2020. 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
- 502 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 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
502 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,927 characters
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:
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.”
- 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
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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.