CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE
Medical device recall Z-2617-2014. Published in FDA’s Enforcement Report on Sep 17, 2014.
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 Sep 17, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 18 states named in where it went
- 748 (307 units US, 441 units OUS) 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 due to a failure of an O2 sensor component associated with the CARESCAPE respiratory modules, the Airway Gas Option and their respective service exchange units.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Avance CS2 and Aisys CS2 Anesthesia Carestations, B40 Patient Monitor -Airway Gas Option N-CAiO modules with B40 Patient Monitor
748 (307 units US, 441 units OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # System ID SGV14019647HA M1199109 SGV14127799HA M1199109 SGV14138150HA M1198397 SGV14148747HA M1199109 SGV14148788HA M1199049 SGV14150001HA M1199109 SGV14150005HA M1199109 SGV14150007HA M1199109 SGV14150037HA M1199109…
Every code shown here, 1,999 characters
Mfg Lot or Serial # System ID SGV14019647HA M1199109 SGV14127799HA M1199109 SGV14138150HA M1198397 SGV14148747HA M1199109 SGV14148788HA M1199049 SGV14150001HA M1199109 SGV14150005HA M1199109 SGV14150007HA M1199109 SGV14150037HA M1199109 SGV14150039HA M1199109 SGV14150041HA M1199109 SGV14150042HA M1199109 SGV14150043HA M1199109 SGV14150044HA M1199109 SGV14150045HA M1199109 SGV14150051HA M1199109 SGV14150060HA M1199109 SGV14150064HA M1199109 SGV14150068HA M1199109 SGV14150071HA M1199109 SGV14150074HA M1199109 SGV14150075HA M1199109 SGV14150079HA M1199109 SGV14150170HA M1199109 SGV14150179HA M1199109 SGV14150180HA M1199109 SGV14150182HA M1199109 SGV14150194HA M1199109 SGV14150195HA M1199109 SGV14150197HA M1199109 SGV14150203HA M1199109 SGV14150204HA M1199109 SGV14150207HA M1199109 SGV14150208HA M1199109 SGV14159469HA M1199109 SGV14159471HA M1199109 SGV14159472HA M1199109 SGV14159484HA M1199109 SGV14159488HA M1199109 SGV14159489HA M1199109 SGV14159490HA M1199109 SGV14159494HA M1199109 SGV14159498HA M1199109 SGV14159499HA M1199109 SGV14159501HA M1199109 SGV14159502HA M1199109 SGV14159504HA M1199109 SGV14159505HA M1199109 SGV14159506HA M1199109 SGV14159507HA M1199109 SGV14159685HA M1199109 SGV14159688HA M1199109 SGV14159689HA M1199109 SGV14159692HA M1199109 SGV14159694HA M1199109 SGV14159695HA M1199109 SGV14159698HA M1199109 SGV14159703HA M1199109 SGV14159707HA M1199109 SGV14159709HA M1199109 SGV14159713HA M1199109 SGV14159716HA M1199109 SGV14159717HA M1199109 SGV14159718HA M1199109 SGV14159722HA M1199109 SGV14159728HA M1199109 SGV14159966HA M1199109 SGV14159971HA M1199109 SGV14159976HA M1199109 SGV14159978HA M1199109 SGV14159979HA M1199109 SGV14159990HA M1199109 SGV14159995HA M1199109 SGV14159999HA M1199109 SGV14160322HA M1199109 SGV14160324HA M1199109 SGV14160325HA M1199109 SGV14160511HA M1199109 SGV14160512HA M1199109 SGV14160513HA M1199109 SGV14160514HA M1199109 SGV14160515HA M1199109 SGV14160519HA M1199109 SGV14160520HA M1199109 SGV14160522HA M1199109 SGV14160524HA…
FDA’s list runs to 17,517 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: CA, CO, FL, GA, IN, KY, LA, MD,MI, NY,NC,OH, PA, SC, TN, TX, VA,WI. OUS: UNITED KINGDOM, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, PHILIPPINES, PANAMA, PAKISTAN, NORWAY, NICARAGUA, NEW ZEALAND, NETHERLANDS, MEXICO, LEBANON, KUWAIT, REPUBLIC OF KOREA, JAPAN, ITALY, INDONESIA, INDIA, GERMANY, FRANCE, FINLAND, EGYPT, CZECH REPUBLIC, COLOMBIA, CHILE, BULGARIA, BELGIUM, AZERBAIJAN, AUSTRALIA.
The states and territories these words name
18 states and territories.
Every one of them
- California
- Colorado
- Florida
- Georgia
- Indiana
- Kentucky
- Louisiana
- Maryland
- Michigan
- North Carolina
- New York
- Ohio
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Virginia
- 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 Aug 8, 2014.
- FDA classified it on Sep 9, 2014.
- FDA’s Enforcement Report published it on Sep 17, 2014.
- FDA terminated it on Sep 8, 2015.
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 17,517 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.