FDAMarch 14, 2018device
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 wa...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
invivo
UPCs
45356424190100884838083523008848380849260088483808353045356448332100884838082113453564621791989803199561
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.2020-09-14
- FDAMonitor for the Functional Imaging System for Magnetic Resonance Imaging System2020-02-06
- FDAXper Flex Cardio Physiomonitoring System, Software version 1.6.0.03882018-09-24
- FDAXper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.03882018-08-03
- FDADynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules. Product Usage: Intended to be used as a post processing software package de...2018-01-24
- FDAXper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG ...2017-11-20
- FDAXper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.2017-08-18
- FDAXper Flex Cardio PhysioMonitoring system 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...2017-08-11
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