Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 23, 2018
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 technic
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 performe…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Invivo Corporation recalled PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483… - a moderate-severity action.
PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483… was recalled by Invivo Corporation in May 23, 2018. Reason: The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may be…. Check the official notice for the remedy. Verify recall #Z-1867-2018 with the FDA Devices before acting.
The recall
Invivo Corporation issued this moderate-severity FDA Devices recall-The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may be….
- Moderate
- severity level
- 4K units
- affected scope
- Class II
- classification
- May 23, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1867-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1867-2018) was formally reported on May 23, 2018, with the manufacturer initiating the action on March 14, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Invivo Corporation is listed as the recalling firm, operating out of Orlando, FL. Federal records list the affected scope as 4375 units.
The documented reason for this recall is: 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 procedu… Distribution data in the federal record shows the product reached: 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…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4375 units
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1867-2018 |
| Date reported | May 23, 2018 |
| Date initiated | March 14, 2018 |
| Recalling firm | Invivo Corporation |
| Firm location | Orlando, FL |
| Affected scope | 4375 units |
| Distribution | 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, H… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1867-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was 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.. Recalled by Invivo Corporation. Units affected: 4375 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 23, 2018. Severity: Moderate. Recall number: Z-1867-2018.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1867-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 23, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.