# FDA recall Z-1867-2018

> **Invivo Corporation** · Class II · device recall initiated 2018-03-14.

## Product

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.

## 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.

## Key facts

- **Recall number:** Z-1867-2018
- **Recalling firm:** Invivo Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-14
- **Report date:** 2018-05-23
- **Termination date:** 2021-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Orlando, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1867-2018

## Citation

> AI Analytics. FDA recall Z-1867-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1867-2018. Source: US FDA. Licensed CC0.

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