Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390
Medical device recall Z-0614-2019. Published in FDA’s Enforcement Report on Dec 26, 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 Dec 26, 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
- 651 units 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?
There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plotted or displayed. 2) The oxygen saturation (SpO2) numeric value displayed on the device may freeze. 3) In auto cycle mode, if the NIBP communication is lost, the pump would not cycle and the non-invasive blood pressure (NIBP) numeric value displayed on the device would not update.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081
651 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
US1251000031 US1311000006 US1407000009 US1419000044 US1438000118 US1446000275 US1547001419 US1610001769 US1625002302 US1638002539 US1450000330 US1746001254 US1311000077 US1417000003 US1511000589 US1319000051 US1537001287 US1736000931…
Every code shown here, 1,998 characters
US1251000031 US1311000006 US1407000009 US1419000044 US1438000118 US1446000275 US1547001419 US1610001769 US1625002302 US1638002539 US1450000330 US1746001254 US1311000077 US1417000003 US1511000589 US1319000051 US1537001287 US1736000931 US1604001618 US1623002140 153 US1251000021 US1203010332 US1604001569 US1407000057 US1324000017 420 421 428 251 616 US1234000045 14 US1537001306 45 US1603001509 US1617002012 US1438000113 US1334000026 US1239000047 US1203010392 US1417000036 1213 US1319000082 US1608001676 US1611001852 US1324000025 US1731000712 US1609001745 US1334000028 US1248000022 US1638002517 US1638002591 US1644002662 US1644002668 US1644002682 US1546001353 US1203010414 US1424000022 US1523000858 US1547001364 US1547001374 US1547001394 US1547001395 US1610001753 US1626002429 US1201010146 US1202010179 US1244000031 US1244000058 US1505000520 US1534001212 US1738001102 US1203010380 US1644002701 US1505000552 US1523000883 US1604001624 US1609001735 US1611001878 US1611001892 US1638002619 US1644002625 US1644002635 US1644002684 US1319000043 US1738002731 US1738002766 US1738002769 US1738002776 US1738002782 US1738002786 US1738002798 US1738002799 US1319000061 US1738002727 US1738002739 US1738002743 US1534001213 US1609001737 US1644002629 US1644002697 US1738002736 US1738002749 US1738002756 US1738002759 US1331000014 US1738002730 US1738002732 US1623002113 US1638002549 US1638002607 US1644002655 US1644002674 US1644002678 US1644002679 US1644002680 US1644002681 US1644002691 US1644002696 US1644002699 US1738002729 US1738002733 US1738002751 US1619002085 US1324000001 US1638002570 US1644002683 US1644002698 US1108010051 US1438000122 US1505000553 US1619002099 US1623002117 US1623002189 US1624002199 US1738002728 US1738002750 US1738002763 US1738002764 US1644002634 US1644002644 US1738002734 US1108010061 US1234000017 US1424000039 US1517000675 US1518000800 US1537001309 US1604001612 US1505000534 US1638002593 US1638002622 US1644002641 US1644002693 US1511000617 US1638002569 US1644002653 US1644002666 US1644002695…
FDA’s list runs to 79,661 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
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 15, 2018.
- FDA classified it on Dec 14, 2018.
- FDA’s Enforcement Report published it on Dec 26, 2018.
- FDA terminated it on Sep 20, 2024.
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 79,661 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.