PHILIPS Xper Flex Cardio Physiomonitoring System
Medical device recall Z-1867-2018. Published in FDA’s Enforcement Report on May 23, 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 May 23, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 4375 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?
The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may be inaccurate. Because ventricular pressure monitoring is only performed in the cardiac catheterization procedure room using the FC2010 device, the FC2020 device, which is used in the Pre or Post-Op Holding Areas, is not impacted by this issue.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers.
4375 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number: 453564241901 Serial Numbers/UDI (if available): US1203010330 US1203010371 US1203010373 US1203010382 US1203010400 US1203010413 US1203010421 US1311000007 US1311000009/ (01)00884838083523(21)US1239000009 US1311000017/…
Every code shown here, 1,991 characters
Model Number: 453564241901 Serial Numbers/UDI (if available): US1203010330 US1203010371 US1203010373 US1203010382 US1203010400 US1203010413 US1203010421 US1311000007 US1311000009/ (01)00884838083523(21)US1239000009 US1311000017/ (01)00884838083523(21)US1331000034 US1239000009 US1331000034 US1231000061 US1108010053 US1202010217 US1234000060 US1337000038 US1337000040 US1337000043 US1343000024 US1334000021 US1234000066 US1202010242/ (01)00884838083523(21)US1202010242 US1244000002/ (01)00884838083523(21)US1244000002 US1251000087/ (01)00884838083523(21)US1251000087 US1202010168 US1203010284 US1244000061 US1251000005 US1203010302/ (01)00884838083523(21)US1203010302 US1244000016/ (01)00884838083523(21)US1203010340 US1231000038/ (01)00884838083523(21)US1231000038 US1234000024/ (01)00884838083523(21)US1234000024 US1244000016/ (01)00884838083523(21)US1244000016 US1244000040/ (01)00884838083523(21)US1244000040 US1244000066/ (01)00884838083523(21)US1244000066 US1251000013/ (01)00884838083523(21)US1251000013 US1311000025/ (01)00884838083523(21)US1311000025 US1319000059/ (01)00884838083523(21)US1319000059 US1337000032/ (01)00884838083523(21)US1337000032 US1231000048/ (01)00884838084926(21)US1231000048 US1251000031/ (01)00884838084926(21)US1251000031 US1304000040/ (01)00884838084926(21)US1304000040 US1334000041/ (01)00884838084926(21)US1334000041 US1107010016 US1107010019 US1107010022 US1107010036 US1108010062 US1109010104 US1202010153 US1202010173 US1202010233 US1203010261 US1203010295 US1203010307 US1203010320 US1203010345 US1203010377 US1231000022 US1234000013 US1234000049 US1239000024 US1239000045 US1244000032 US1244000055 US1248000023 US1251000030 US1251000033 US1251000052 US1251000077 US1304000020 US1311000069 US1319000009 US1319000016 US1319000030 US1319000069 US1324000008 US1324000014 US1324000039 US1328000002 US1331000040 US1337000055 US1343000001 US1343000009 US1343000027 US1343000059 US1343000073 US1239000002 US1352000047 US1324000011 US1319000038 US1239000019…
FDA’s list runs to 114,905 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 - USA (nationwide) Distribution including Puerto Rico., and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Cyprus, Egypt, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Italy, Kazakhstan, Kenya, Malaysia, Mexico, Mauritius, Netherlands, New Zealand, Pakistan, Philippines, Poland, Romania, Russian Fed, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom, Utd. Arab Emir, Uzbekistan and Vietnam.
The states and territories these words name
- Puerto Rico
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 Mar 14, 2018.
- FDA classified it on May 14, 2018.
- FDA’s Enforcement Report published it on May 23, 2018.
- FDA terminated it on Apr 30, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Invivo Corporation, of Orlando, FL.
- 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 114,905 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.