IntelliVue G7m Anesthesia Gas Module
Medical device recall Z-2689-2020. Published in FDA’s Enforcement Report on Jul 29, 2020.
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 Jul 29, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 3075 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 device may experience an interruption of gas measurement due to a firmware issue, ceasing measurement and display of gas levels and generating one or more technical or INOP alarms.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173
3075, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial numbers: DE43804813 DE43804952 DE43804945 DE43806034 DE43806054 DE43803806 DE43803822 DE43803824 DE43803907 DE43803911 DE43803915 DE43803983 DE43803986 DE43803988 DE43803989 DE43806224 DE43803973 DE43803895 DE43804009 DE43803778…
Every code shown here, 1,996 characters
Serial numbers: DE43804813 DE43804952 DE43804945 DE43806034 DE43806054 DE43803806 DE43803822 DE43803824 DE43803907 DE43803911 DE43803915 DE43803983 DE43803986 DE43803988 DE43803989 DE43806224 DE43803973 DE43803895 DE43804009 DE43803778 DE43803752 DE43803762 DE43803766 DE43803772 DE43803773 DE43803774 DE43803790 DE43805609 DE43804358 DE43804391 DE43805722 DE43804085 DE43804093 DE43803753 DE43803754 DE43803769 DE43803823 DE43803831 DE43803836 DE43803841 DE43805272 DE43805280 DE43805291 DE43805295 DE43803802 DE43803812 DE43803814 DE43803815 DE43803826 DE43803828 DE43805705 DE43805709 DE43805713 DE43805717 DE43805720 DE43805725 DE43805735 DE43805744 DE43805515 DE43805516 DE43805522 DE43805526 DE43805574 DE43805715 DE43805734 DE43804627 DE43804634 DE43804636 DE43804560 DE43804563 DE43804566 DE43804567 DE43804576 DE43804090 DE43804102 DE43804017 DE43804200 DE43804204 DE43804216 DE43804880 DE43804133 DE43804138 DE43805110 DE43805130 DE43806607 DE43806724 DE43804918 DE43804927 DE43806373 DE43806511 DE43806567 DE43806585 DE43805905 DE43805907 DE43806483 DE43806494 DE43806500 DE43806503 DE43806117 DE43806142 DE43806144 DE43805411 DE43804841 DE43805620 DE43805459 DE43803936 DE43806568 DE43804140 DE43804951 DE43805619 DE43804302 DE43805964 DE43805058 DE43805060 DE43805197 DE43805200 DE43805204 DE43805205 DE43805213 DE43806631 DE43805333 DE43805338 DE43805349 DE43805352 DE43805904 DE43805908 DE43805909 DE43805111 DE43805113 DE43805116 DE43805122 DE43805124 DE43805331 DE43805191 DE43803708 DE43803716 DE43803718 DE43803855 DE43806326 DE43806329 DE43806334 DE43806335 DE43806338 DE43806462 DE43806468 DE43805952 DE43803893 DE43803902 DE43803987 DE43806062 DE43806064 DE43806078 DE43806532 DE43806077 DE43806084 DE43806090 DE43805271 DE43806439 DE43806558 DE43806197 DE43806244 DE43804593 DE43805842 DE43805867 DE43805873 DE43805991 DE43805992 DE43805998 DE43806001 DE43806005 DE43806007 DE43806009 DE43806015 DE43806022 DE43804824 DE43803972 DE43803959 DE43803974 DE43803978 DE43804304…
FDA’s list runs to 33,838 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 distribution.
These words name no state.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Jun 25, 2020.
- FDA classified it on Jul 23, 2020.
- FDA’s Enforcement Report published it on Jul 29, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips North America, LLC, of Andover, MA.
- 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 33,838 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.