Invivo recalls
Invivo appears in 19 official U.S. recall notices indexed by RecallRadar, most recently on 2020-10-28.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 19 |
|---|---|
| Published | 2012-12-12 to 2020-10-28 |
| By agency | FDA Device (19) |
| By classification | Class II (18), Class III (1) |
| By status | terminated (17), completed (1), ongoing (1) |
| Distribution named in notices | AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, WA, WI, WV |
Recalls
- MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of…
FDA Device · Class III · 2020-10-28 · Invivo
Reason: The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress. - Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
FDA Device · Class II · 2020-03-11 · Invivo
Reason: Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor. - Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
FDA Device · Class II · 2018-11-21 · Invivo
Reason: The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the keyboard, activate or deactivate t… - Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
FDA Device · Class II · 2018-09-26 · Invivo
Reason: Released with an incorrect, older firmware version installed. May result in intermittent loss of ECG monitoring, inaccurate ECG amplitude display and or auxiliary output, and inaccurate heart rate (HR) displayed due to… - Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart…
FDA Device · Class II · 2018-06-13 · Invivo
Reason: While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon in the upper right corner of this window. - PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international…
FDA Device · Class II · 2018-05-23 · Invivo
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 procedur… - DynaCad software consist of an MR Analysis Server software and the viewer workstation software
FDA Device · Class II · 2018-04-11 · Invivo
Reason: Following update from 3.3 to 3.5 of the DynaCAD software it was noted that the Ktrans map was not rendered correctly on the DynaCad Client. The defect causes the pharmacokinetic (PK) color maps to display incorrectly wh… - Xper Flex Cardio Physiomonitoring system
FDA Device · Class II · 2017-12-27 · Invivo
Reason: Intermittent communication between the host system and the FlexCardio - Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart…
FDA Device · Class II · 2017-11-15 · Invivo
Reason: Intermittent communication between the host system and the Flex Cardio - Philips Expression Information Portal (IP5) Model 865471
FDA Device · Class II · 2016-09-28 · Invivo
Reason: Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notification was sent August 22, 2014. - The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet…
FDA Device · Class II · 2016-09-14 · Invivo
Reason: Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze - Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems
FDA Device · Class II · 2016-09-07 · Invivo
Reason: A diode was inadvertently not assembled into the system, which may result in coil overheating - Philips Expression MR200 MRI Patient Monitoring System
FDA Device · Class II · 2015-01-21 · Invivo
Reason: The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock. - Philips Expression MR200 MRI Patient Monitoring System
FDA Device · Class II · 2014-10-22 · Invivo
Reason: Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement. - Philips Expression MR200 MRI Patient Monitoring System Model 866120
FDA Device · Class II · 2014-10-08 · Invivo
Reason: During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to po… - Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monit…
FDA Device · Class II · 2014-08-27 · Invivo
Reason: The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between the IP5 and host monitoring system. - Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression Information Portal (Model IP5) a display and device cont…
FDA Device · Class II · 2014-03-05 · Invivo
Reason: Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling their Expression Information Portal (Model IP5). Three different IP5 devices lost audio during use. - Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device m…
FDA Device · Class II · 2014-02-26 · Invivo
Reason: Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression Information Portal (Model IP5). Upon power up, the IP5 may fail to produce audio. - Invivo Corporation Expression MRI Patient Monitoring System
FDA Device · Class II · 2012-12-12 · Invivo
Reason: Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression MRI Patient Monitoring System because during transport of the systems cart with a docked Display Controller Unit (DCU)…