GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX
Medical device recall Z-1808-2014. Published in FDA’s Enforcement Report on Jun 25, 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 Jun 25, 2014. 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
- 4,961 (1,946 units US, 3,015 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?
Potential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the gas sampling pump hex screw in the module pump unit may lead to pump failure that may cause loss of respiratory airway gas parameter monitoring. If this issue occurs, the monitor will show an alarm note on monitor screen of either “Low gas sample flow” or “Check sample gas out”.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
4,961 (1,946 units US, 3,015 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 # 6704120 6704126 6704128 6704129 6704132 6704133 6704134 6704138 6704143 6704146 6704147 6704150 6704151 6704152 6705240 6705241 6705242 6705245 6705246 6705248 6705249 6705254 6705256 6705258 6705259 6705261 6705262…
Every code shown here, 1,996 characters
Mfg Lot or Serial # 6704120 6704126 6704128 6704129 6704132 6704133 6704134 6704138 6704143 6704146 6704147 6704150 6704151 6704152 6705240 6705241 6705242 6705245 6705246 6705248 6705249 6705254 6705256 6705258 6705259 6705261 6705262 6705263 6705264 6705266 6705271 6705274 6705276 6705277 6705278 6705279 6705280 6705282 6705283 6705284 6705287 6705313 6705316 6705327 6705328 6705329 6705333 6705334 6705336 6705337 6705338 6705339 6705340 6705341 6705348 6705352 6705360 6706475 6706477 6706478 6706479 6706480 6706485 6706487 6706489 6706490 6707891 6707892 6707893 6707894 6707896 6707897 6707899 6707901 6707902 6707904 6707906 6707908 6707909 6707911 6707912 6707913 6707914 6707916 6707917 6707918 6707920 6707921 6707922 6707924 6707926 6707928 6707929 6707932 6707933 6707934 6707936 6707939 6707940 6707941 6707943 6707944 6707946 6707948 6707949 6707950 6707951 6707953 6707955 6707956 6707960 6707962 6707967 6707968 6707971 6707974 6707975 6707976 6707978 6707980 6707981 6707985 6707986 6708993 6708994 6708995 6708996 6709002 6709003 6709004 6709006 6709170 6709171 6709172 6709173 6709176 6709179 6709180 6709181 6709221 6709230 6709232 6709235 6710264 6710271 6710274 6710280 6710281 6710282 6710283 6710284 6710285 6710286 6710287 6710289 6710543 6710545 6710562 6710565 6710566 6710567 6710568 6710569 6710570 6710574 6710575 6710576 6710579 6710580 6710581 6710583 6710588 6710590 6710591 6710599 6710600 6710602 6710604 6710606 6711237 6711246 6711249 6711253 6711256 6711259 6711261 6711262 6711266 6711271 6711277 6711278 6711280 6711282 6711284 6711641 6711642 6711644 6711651 6711668 6711669 6711685 6711687 6713073 6713077 6713079 6713080 6713082 6713083 6713084 6713088 6713089 6713093 6713095 6713100 6713101 6713102 6713103 6713107 6713109 6713111 6713113 6713114 6713116 6713121 6713122 6713124 6713125 6713135 6713139 6713140 6713142 6713143 6713148 6713150 6713152 6713154 6713155 6713156 6713159 6713160 6713162 6713163 6713166 6713169 6713172 6713173 6713174…
FDA’s list runs to 39,707 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 Distribution - US (nationwide): All states in continental USA including DC except DE, ME, ND, RI & VT. and the countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GHANA, HONG KONG, HUNGARY, INDIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAHKSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT LEBANON, LITHUANIA, MACEDONIA, MAURITIUS,MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY,, PANAMA, PERU, POLAND, PORTUGAL, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIET NAM, and URUGUAY.
The states and territories these words name
- District of Columbia
They leave out Delaware, Maine, North Dakota, Rhode Island and Vermont.
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 May 23, 2014.
- FDA classified it on Jun 17, 2014.
- FDA’s Enforcement Report published it on Jun 25, 2014.
- FDA terminated it on Oct 21, 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 39,707 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
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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.