FDASeptember 14, 2014device
Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 MRI Patient Monitoring System.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notification was sent August 22, 2014.
What to do
FDA enforcement status: Terminated
Brands named
invivo
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
- FDAPHILIPS 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...2018-03-14
- 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
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