GE Healthcare, Aestiva MRI, 1006-9310-000
Medical device recall Z-0679-2016. Published in FDA’s Enforcement Report on Jan 27, 2016.
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 Jan 27, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 84 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?
The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The Aestiva/5 MRI anesthesia system provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment.
84, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
AMTU01048 AMTU01023 AMTU00163 AMTU01050 AMTU00172 AMTU00175 AMTU00176 AMTU01034 AMTU01047 AMTU01055 AMTU01001 AMTU01002 AMTU01021 AMTU01044 AMTU01042 AMTU01015 AMTU00178 AMTU00179 AMTU00162 AMTU01000 AMTU01012 AMTU01041 AMTU00167 AMTU01019…
Every code shown here, 839 characters
AMTU01048 AMTU01023 AMTU00163 AMTU01050 AMTU00172 AMTU00175 AMTU00176 AMTU01034 AMTU01047 AMTU01055 AMTU01001 AMTU01002 AMTU01021 AMTU01044 AMTU01042 AMTU01015 AMTU00178 AMTU00179 AMTU00162 AMTU01000 AMTU01012 AMTU01041 AMTU00167 AMTU01019 AMTU00177 AMTU01049 AMTU00171 AMTU00164 AMTU01066 AMTU01006 AMTU00168 AMTU01061 AMTU01060 AMTU01056 AMTU01057 AMTU01073 AMTU00154 AMTU00166 AMTU00174 AMTU01005 AMTU01035 AMTU00150 AMTU01024 AMTU01025 AMTU01026 AMTU01027 AMTU01037 AMTU00152 AMTU01040 AMTU01022 AMTU00157 AMTU00158 AMTU00159 AMTU00160 AMTU00170 AMTU01018 AMTU01009 AMTU01032 AMTU01046 AMTU01045 AMTU01020 AMTU01008 AMTU00165 AMTU01013 AMTU01014 AMTU01033 AMTU01016 AMTU01036 AMTU01038 AMTU00151 AMTU00169 AMTU01003 AMTU00161 AMTU01010 AMTU01064 AMTU01011 AMTU01004 AMTU01017 AMTU01031 AMTU01053 AMTU01058 AMTU01059 AMTU01039 AMTU01007
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 Distribution - US (nationwide including PR except NH, VT, & WY. Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.
The states and territories these words name
- Puerto Rico
They leave out New Hampshire, Vermont and Wyoming.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 Dec 15, 2015.
- FDA classified it on Jan 21, 2016.
- FDA’s Enforcement Report published it on Jan 27, 2016.
- FDA terminated it on Sep 21, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Medical Systems, 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
-
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.