IntelliVue X3 Patient Monitor.
Medical device recall Z-1315-2018. Published in FDA’s Enforcement Report on Apr 18, 2018.
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 Apr 18, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 975 (updated 8-14-18) 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 NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected NBP cuff, which is leading to wrong internal NBP setting. Furthermore, occasionally the Monitor shows the Check Touch Input message and the monitor is inoperable with the touch interface.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
IntelliVue X3 Patient Monitor.
975 (updated 8-14-18), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model 867030 - All devices shipped from June 2017 (Updated 8-14-18) Serial No. DE61102743 DE61103908 DE61102877 DE61105176 DE61102652 DE61102659 DE61104847 DE61101457 DE61101460 DE61100472 DE61101176 DE61100535 DE61100101 DE61100544…
Every code shown here, 1,993 characters
Model 867030 - All devices shipped from June 2017 (Updated 8-14-18) Serial No. DE61102743 DE61103908 DE61102877 DE61105176 DE61102652 DE61102659 DE61104847 DE61101457 DE61101460 DE61100472 DE61101176 DE61100535 DE61100101 DE61100544 DE61101308 DE61101569 DE61101001 DE61101266 DE61100411 DE61101279 DE61101110 DE61100173 DE61101283 DE61100511 DE61100153 DE61101302 DE61101480 DE61100832 DE61100139 DE61100176 DE61100845 DE61100201 DE61100558 DE61100243 DE61100466 DE61100240 DE61100293 DE61100678 DE61100910 DE61100202 DE61101132 DE61100561 DE61100172 DE61101010 DE61101158 DE61101409 DE61101427 DE61101218 DE61100700 DE61100526 DE61101004 DE61100927 DE61101441 DE61100755 DE61100753 DE61101456 DE61101462 DE61101463 DE61101464 DE61101465 DE61101466 DE61101470 DE61101471 DE61101475 DE61101476 DE61101478 DE61101479 DE61101481 DE61101483 DE61101484 DE61101486 DE61101487 DE61101489 DE61101494 DE61101496 DE61101501 DE61101507 DE61101508 DE61101512 DE61101516 DE61101521 DE61100469 DE61101172 DE61101178 DE61101180 DE61101181 DE61101182 DE61101184 DE61101185 DE61101188 DE61101189 DE61101190 DE61101194 DE61101196 DE61101197 DE61101198 DE61101199 DE61101201 DE61101203 DE61101204 DE61101205 DE61101206 DE61101207 DE61101208 DE61101209 DE61101210 DE61101211 DE61101212 DE61101213 DE61101214 DE61101216 DE61101221 DE61101229 DE61101232 DE61101233 DE61101235 DE61101236 DE61101239 DE61101240 DE61101241 DE61101244 DE61101246 DE61101247 DE61101248 DE61101249 DE61101251 DE61101252 DE61101253 DE61101254 DE61101255 DE61101256 DE61101259 DE61101260 DE61101261 DE61101262 DE61101263 DE61101264 DE61101268 DE61101269 DE61101270 DE61101271 DE61101272 DE61100534 DE61100538 DE61100539 DE61100542 DE61100543 DE61100563 DE61100565 DE61100658 DE61100659 DE61100695 DE61100698 DE61100100 DE61100102 DE61100103 DE61100104 DE61100106 DE61100107 DE61100109 DE61100110 DE61100111 DE61100113 DE61100114 DE61100115 DE61100116 DE61100117 DE61100118 DE61100119 DE61100120 DE61100121 DE61100122 DE61100123 DE61100124…
FDA’s list runs to 10,803 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.
48 Foreign Accounts
These words name no state.
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 Nov 17, 2017.
- FDA classified it on Apr 6, 2018.
- FDA’s Enforcement Report published it on Apr 18, 2018.
- FDA terminated it on Sep 16, 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 10,803 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.