Recall Register

Invivo Corporation: FDA recalls

FDA enforcement reports name Invivo Corporation as the recalling firm in 19 events. The events have 19 product records. The recalls started from 2012 to 2020. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

19 events, newest first.

FDA enforcement events of Invivo Corporation
InitiatedProduct (first record)TypeClassRecordsStatus
14 Sep 2020MR 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.DeviceClass III1Terminated
6 Feb 2020Monitor for the Functional Imaging System for Magnetic Resonance Imaging SystemDeviceClass II1Terminated
24 Sep 2018Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388DeviceClass II1Completed
3 Aug 2018Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388DeviceClass II1Terminated
14 Mar 2018PHILIPS 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. Its…DeviceClass II1Terminated
24 Jan 2018DynaCad 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 designed to provide a…DeviceClass II1Terminated
20 Nov 2017Xper 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 (electrocardiogram),…DeviceClass II1Ongoing
18 Aug 2017Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.DeviceClass II1Terminated
11 Aug 2017Xper 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 providers, such as…DeviceClass II1Terminated
6 May 2016Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.DeviceClass II1Terminated
19 Oct 2015The 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.DeviceClass II1Terminated
22 Oct 2014Philips Expression MR200 MRI Patient Monitoring System.DeviceClass II1Terminated
14 Sep 2014Philips 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.DeviceClass II1Terminated
8 Sep 2014Philips Expression MR200 MRI Patient Monitoring System Model 866120DeviceClass II1Terminated
5 Sep 2014Philips Expression MR200 MRI Patient Monitoring SystemDeviceClass II1Terminated
30 Jun 2014Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures.DeviceClass II1Terminated
4 Dec 2013Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI procedure from the MR control room, induction room, or recovery room and then outputs the measured patient data to a…DeviceClass II1Terminated
3 Oct 2013Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression Information Portal (Model IP5) a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professional to remotely monitor the vital signs of patients undergoing MRI…DeviceClass II1Terminated
15 Oct 2012Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the MR scanner.DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Invivo Corporation: events for each product type
TypeEvents
Device19
Invivo Corporation: events in each class
ClassEvents
Class II18
Class III1
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
1

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Invivo Corporation, by the year that the recall started. The largest year is 2014, with 5 events.

Official channels

Cite this page

Recall Register. Invivo Corporation: FDA recalls. https://recallregister.com/firm/invivo-corporation/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
FL

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Invivo Corporation have?
Class II: 18 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Invivo Corporation?
FDA event 86501, which the firm started on 14 Sep 2020. The first product in the record is: 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 interest that can be interpreted by a trained physician.
How many FDA recalls of Invivo Corporation have the status Ongoing?
1 event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.