23
May
2018

Recall – Cardio Physiomonitoring System display bug

0

Company: Invivo Corporation
Date of Enforcement Report 5/23/2018
Class II:

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. Recall Number: Z-1867-2018

REASON
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.

RECALLING FIRM/MANUFACTURER
Invivo Corporation, Orlando FL on 3/14/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4375 units

DISTRIBUTION
Nationwide and Internationally

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