Hearth Record

IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot

Medical device recall Z-2547-2019. Published in FDA’s Enforcement Report on Sep 25, 2019.

FDA’s own record, on accessdata.fda.gov

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 25, 2019. Copied from openFDA on Oct 20, 2026.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some Installations

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded twisted pair data cable bundle and is a component of the Philips Remote Antenna (PN 867151). The Remote Antenna is used with IntelliVue MX40 Patient Worn Monitors in the USA, to extend the coverage area of a Core Access Point for the wireless Smart-hopping system.

1790 units, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

All Remote Antennas (PN 867151) shipped since May 2019 with marked “CM” rated coax data cable. Serial Numbers: DK82001096 DK82000314 DK82000358 DK82000457 DK82000465 DK82000610 DK82000650 DK82000747 DK82000773 DK82000939 DK82001008…

Every code shown here, 1,992 characters

All Remote Antennas (PN 867151) shipped since May 2019 with marked “CM” rated coax data cable. Serial Numbers: DK82001096 DK82000314 DK82000358 DK82000457 DK82000465 DK82000610 DK82000650 DK82000747 DK82000773 DK82000939 DK82001008 DK82001074 DK82001083 DK74900244 DK74900242 DK82000679 DK82000946 DK82000970 DK82000971 DK82000974 DK82001114 DK82001124 DK82001130 DK82001131 DK82001132 DK82001174 DK82001218 DK82001311 DK82101505 DK82101533 DK82101566 DK82101911 DK82102050 DK82102053 DK82102273 DK82000975 DK82000980 DK82000991 DK82000999 DK82001000 DK82001021 DK82001111 DK82001297 DK82001301 DK82001310 DK82101609 DK82101824 DK82101910 DK82102278 DK74900162 DK74900164 DK74900167 DK74900180 DK74900236 DK74900268 DK74900269 DK74900278 DK74900288 DK74900290 DK74900300 DK74900303 DK82000778 DK82000782 DK82000795 DK82000603 DK82000635 DK82000719 DK82000828 DK82000852 DK82000853 DK82000898 DK74900182 DK74900212 DK74900232 DK74900281 DK74900284 DK74900287 DK74900304 DK74900307 DK82000399 DK82000446 DK82000459 DK82000569 DK82000587 DK82000730 DK82000734 DK82000766 DK82000777 DK82000903 DK82000941 DK82000943 DK82000694 DK82000711 DK82000832 DK82000842 DK82000918 DK82000920 DK82000960 DK82000961 DK82001060 DK82001065 DK82001085 DK82001095 DK82001189 DK82001190 DK82001203 DK82001206 DK82001229 DK82001232 DK82001240 DK82001241 DK82000845 DK82000847 DK82000849 DK82000988 DK82001056 DK82001057 DK82001166 DK82001181 DK82001187 DK82001210 DK82001211 DK82001216 DK82001264 DK82001265 DK82001274 DK74900165 DK74900168 DK74900185 DK74900233 DK74900292 DK74900293 DK74900296 DK82000338 DK82000433 DK82000434 DK82000437 DK82000440 DK82000454 DK82000455 DK82000496 DK82000497 DK82000527 DK82000592 DK82000607 DK82000608 DK74900267 DK74900285 DK74900291 DK82000339 DK82000417 DK82000422 DK82000441 DK82000444 DK82000447 DK82000515 DK82000516 DK82000517 DK82000612 DK82000678 DK82103352 DK82101389 DK82101402 DK82101412 DK82101547 DK82102884 DK82102888 DK82102905 DK82103224 DK82102177 DK82102563…

FDA’s list runs to 19,800 characters. The first part is shown; the rest is on FDA’s record.

Source:

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.

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.

Source:

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Aug 23, 2019.
  • FDA classified it on Sep 19, 2019.
  • FDA’s Enforcement Report published it on Sep 25, 2019.
  • FDA terminated it on Jan 3, 2024.
Source:

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.
Source:

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 19,800 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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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