GE Healthcare, Aisys CS2 anesthesia..
Medical device recall Z-1381-2016. Published in FDA’s Enforcement Report on Apr 20, 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 Apr 20, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 41 states named in where it went
- 5496 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?
GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Aisys CS2 anesthesia..
5496, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
APWU00723 APWU00724 APWU01057 APWU01058 APWU01059 APWU02682 APWU02683 APWU02684 APWU02685 APWU02686 APWU02687 APWU02688 APWU02689 APWU02690 APWU02691 APWU02692 APWU02693 APWU02694 APWU02695 APWU01240 APWU01241 APWU01242 APWU01243 APWU01244…
Every code shown here, 2,000 characters
APWU00723 APWU00724 APWU01057 APWU01058 APWU01059 APWU02682 APWU02683 APWU02684 APWU02685 APWU02686 APWU02687 APWU02688 APWU02689 APWU02690 APWU02691 APWU02692 APWU02693 APWU02694 APWU02695 APWU01240 APWU01241 APWU01242 APWU01243 APWU01244 APWU01785 APWU01827 APWU01988 APWU01989 APWU01990 APWU01991 APWU01992 APWU01993 APWU01994 APWU01995 APWU01996 APWU01997 APWU02708 APWT02996 APWT02384 APWT02254 APWT02255 APWT02256 APWT02257 APWT02258 APWT03126 APWT03127 APWT02326 APWU02707 APWT00391 APWT00392 APWT00393 APWT00394 APWT00395 APWU01576 APWU01577 APWU01578 APWU00363 APWU00364 APWU00365 APWU00366 APWT00898 APWT00899 APWT02417 APWV00144 APWU00707 APWU00708 APWU00709 APWU00710 APWU00711 APWU02287 APWU00190 APWU02166 APWU02167 APWU02168 APWU02169 APWU02170 APWU02171 APWU02172 APWU02316 APWU02317 APWU02318 APWU02319 APWU02320 APWU02321 APWU02322 APWT02043 APWT02044 APWT02045 APWT02046 APWT02047 APWT02048 APWT02049 APWT02050 APWT02051 APWT02052 APWU00712 APWT03125 APWT02250 APWT02251 APWU00505 APWU00506 APWU00507 APWT02328 APWT02329 APWT02330 APWT02331 APWT02332 APWU00474 APWU00475 APWU00476 APWU00477 APWU00478 APWU00479 APWT00589 APWT00590 APWT00591 APWT00592 APWT00593 APWT00603 APWT00977 APWT00978 APWU01486 APWU01487 APWU01488 APWU01489 APWU01490 APWU01491 APWU01492 APWU01493 APWU01494 APWU01495 APWT00561 APWT00562 APWU00611 APWU00612 APWU00613 APWU00614 APWU00145 APWU00146 APWU02163 APWU02164 APWU02165 APWU02051 APWU02052 APWU01825 APWU01909 APWU01599 APWU01600 APWU01601 APWU01602 APWU02017 APWU02018 APWU02019 APWU02020 APWT02407 APWT02408 APWT02409 APWU02576 APWT02385 APWU02237 APWU02648 APWU00297 APWU01054 APWU01055 APWU01056 APWU01608 APWU01609 APWU01610 APWU01611 APWU01612 APWU01613 APWU01614 APWU01615 APWU02066 APWU02067 APWT02750 APWT02746 APWT02747 APWT02748 APWT02749 APWT02751 APWT02752 APWT02851 APWT02852 APWT02853 APWT02854 APWT02855 APWT02856 APWT02857 APWT02858 APWU00576 APWU00579 APWU00580 APWU00581 APWU00582 APWU00583 APWU00584 APWU00585 APWU00586 APWU00587…
FDA’s list runs to 54,951 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.
US: AL, AZ, AR, CA, CO, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI. OUS: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, CANDA, CHILE, CHINA, COLOMBIA, CROATIA, CR¿CHE REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY,GREECE, HELSINKI, HONG KONG, HUNGARIA, ICELAND, INDIA, IRAQ, IRELAND, ITA LY, JAPAN, JORDAN, KAZAKHSTAN, KOREA, KUWAIT, MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM,URUGUAY, VIETNAM.
The states and territories these words name
41 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- District of Columbia
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- North Carolina
- Nebraska
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
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 Feb 17, 2016.
- FDA classified it on Apr 13, 2016.
- FDA’s Enforcement Report published it on Apr 20, 2016.
- FDA terminated it on Sep 4, 2018.
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.”
- FDA’s list of codes runs to 54,951 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.