FDAOctober 19, 2015device
The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze
What to do
FDA enforcement status: Terminated
Brands named
invivo
UPCs
4535642419011107901008645356424191145356424359145356424360145356424361120115000283453564428541453564483321453564483331
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
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →