IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals…
Medical device recall Z-2328-2016. Published in FDA’s Enforcement Report on Aug 10, 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 Aug 10, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 50,495 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?
If an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patients current condition.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.
50,495, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers listed for US/VA/DOD Consignees. For OUS serial numbers, plesae refer to customer list. DE35122625 DE35142133 DE35142134 DE35115647 DE35106078 DE35129184 DE35129185 DE35147659 DE35147653 DE35119998 DE35119999 DE35120000…
Every code shown here, 1,995 characters
Serial Numbers listed for US/VA/DOD Consignees. For OUS serial numbers, plesae refer to customer list. DE35122625 DE35142133 DE35142134 DE35115647 DE35106078 DE35129184 DE35129185 DE35147659 DE35147653 DE35119998 DE35119999 DE35120000 DE35120001 DE35120021 DE35120022 DE35120023 DE35120024 DE35120025 DE35120026 DE35120027 DE35120028 DE35120029 DE35120030 DE35120031 DE35120032 DE35120034 DE35120035 DE35120036 DE35120037 DE35120038 DE35120039 DE35120040 DE35120041 DE35120042 DE35120043 DE35120044 DE35120045 DE35120046 DE35120047 DE35120048 DE35120052 DE35120053 DE35120055 DE35120056 DE35120057 DE35120058 DE35120059 DE35120060 DE35120061 DE35120062 DE35120063 DE35120064 DE35120065 DE35120067 DE35120068 DE35120069 DE35120071 DE35120072 DE35120079 DE35120080 DE35120081 DE35120082 DE35120083 DE35120084 DE35120085 DE35120086 DE35120091 DE35127131 DE35127132 DE35127133 DE35127135 DE35120322 DE35120323 DE35120324 DE35120325 DE35120326 DE35120327 DE35120328 DE35120329 DE35120330 DE35120488 DE35120489 DE35120490 DE35120491 DE35120492 DE35120493 DE35120494 DE35120495 DE35120496 DE35120497 DE35120498 DE35120499 DE35120501 DE35120502 DE35120503 DE35120504 DE35120505 DE35120506 DE35120507 DE35120508 DE35120509 DE35120510 DE35120511 DE35120514 DE35120515 DE35120516 DE35120517 DE35120518 DE35120519 DE35120520 DE35120521 DE35120522 DE35120523 DE35120524 DE35120525 DE35120526 DE35120527 DE35120528 DE35120529 DE35120530 DE35120531 DE35120532 DE35120533 DE35120534 DE35120535 DE35120536 DE35120537 DE35120538 DE35120539 DE35120540 DE35120541 DE35120542 DE35120543 DE35120544 DE35120545 DE35120546 DE35120547 DE35120548 DE35120549 DE35120550 DE35120551 DE35120552 DE35120553 DE35120554 DE35120555 DE35120556 DE35120557 DE35127022 DE35127023 DE35127024 DE35126986 DE35126987 DE35126989 DE35126993 DE35126994 DE35126996 DE35126997 DE35126999 DE35127000 DE35127001 DE35127002 DE35127003 DE35127004 DE35127005 DE35127006 DE35127007 DE35127008 DE35127010 DE35127011 DE35127012 DE35127013 DE35127014…
FDA’s list runs to 225,314 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
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?
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 Jul 26, 2016.
- FDA classified it on Aug 3, 2016.
- FDA’s Enforcement Report published it on Aug 10, 2016.
- FDA terminated it on Jul 14, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Electronics North America Corporation, 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 225,314 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.