The Recall Desk

Manufacturer

Invivo Corporation

19 recalls in our database name Invivo Corporation as the manufacturing or recalling firm.

What the numbers show

Total
19
Critical
0
Severe
0
Most recent
2020-10-28

Of the 19 recalls from Invivo Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–19 of 19

  • LowFDA (Devices)·Z-0126-2021·2020-10-28

    Invivo MR Coils Recalled for Incorrect IPX1 Water Ingress Rating Label

    Invivo Corporation is recalling 12,764 MR Coils because the labels were mistakenly printed with an IPX1 rating symbol, which indicates water ingress protection.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1440-2020·2020-03-11

    Invivo Recalls MRI Monitor Adapters Due to Insufficient Shielding

    Invivo Corporation is recalling 75 SensaVue DVI adapters for MRI monitors because they have insufficient shielding. The units were distributed in the U.S. and several foreign countries.

    Product
    Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0462-2019·2018-11-21

    Invivo Xper Flex Cardio Physiomonitoring System Software Recall

    Invivo Corporation is recalling 76 units of the Xper Flex Cardio Physiomonitoring System due to a software defect that causes Invasive Blood Pressure values to freeze on the display.

    Product
    Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3192-2018·2018-09-26

    Invivo Xper Flex Cardio Physiomonitoring System Recalled for Firmware Error

    Invivo Corporation is recalling 38 Xper Flex Cardio Physiomonitoring Systems distributed in the Netherlands due to incorrect firmware that may cause inaccurate ECG and heart rate displays.

    Product
    Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2115-2018·2018-06-13

    Invivo Xper Flex Cardio Physiomonitoring System Recalled for Software Defect

    Invivo Corporation is recalling Xper Flex Cardio Physiomonitoring Systems because users may inadvertently close the Full Disclosure Control Window using the ESC key.

    Product
    Xper 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1867-2018·2018-05-23

    Invivo Xper Flex Cardio Physiomonitoring System Recalled for Inaccurate Pressure Readings

    Invivo is recalling 4,375 Xper Flex Cardio Physiomonitoring Systems because ventricular end-diastolic pressure readings may be inaccurate. The issue affects specific model numbers used in cardiac catheterization rooms.

    Product
    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-inv
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1289-2018·2018-04-11

    Invivo DynaCAD Software Recalled for Incorrect Pharmacokinetic Map Display

    Invivo Corporation is recalling DynaCAD software versions 3.4 and 3.5 because pharmacokinetic and ADC maps may display incorrectly on remote clients, potentially leading to underestimated values.

    Product
    DynaCad 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 processi
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0263-2018·2017-12-27

    Invivo Recalls Xper Flex Cardio Physiomonitoring Systems Due to Communication Issues

    Invivo Corporation is recalling 4,535 Xper Flex Cardio Physiomonitoring systems because of intermittent communication between the host system and the device.

    Product
    Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-0082-2018·2017-11-15

    Invivo Recalls Xper Flex Cardio PhysioMonitoring Systems Due to Communication Errors

    Invivo Corporation is recalling 529 Xper Flex Cardio PhysioMonitoring systems because of intermittent communication issues between the host system and the device.

    Product
    Xper 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 profe
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2867-2016·2016-09-28

    Invivo Recalls Philips Expression IP5 MRI Patient Monitoring Units

    Invivo Corporation is recalling 639 Philips Expression Information Portal (IP5) units because display numerics may freeze and menu keys may disable after extended run time.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2760-2016·2016-09-14

    Invivo Xper Flex Cardio Patient Monitoring System Recalled for Frozen Display

    Invivo Corporation is recalling Xper Flex Cardio Patient Monitoring Systems because SpO2 and NIBP measurements may freeze on the display.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2688-2016·2016-09-07

    Invivo Breast MRI Auxiliary Table Recalled Due to Missing Diode

    Invivo Corporation is recalling three breast MRI auxiliary tables because a missing diode may cause the coil to overheat.

    Product
    Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0958-2015·2015-01-21

    Invivo Recalls Philips Expression MR200 MRI Patient Monitoring Systems

    Invivo Corporation is recalling 20 Philips Expression MR200 MRI Patient Monitoring Systems due to capacitor shorts that may cause electrical shock or loss of monitoring.

    Product
    Philips Expression MR200 MRI Patient Monitoring System.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0069-2015·2014-10-22

    Invivo Recalls Philips Expression MR200 MRI Patient Monitoring Systems

    Invivo Corporation is recalling 24 Philips Expression MR200 MRI Patient Monitoring Systems because they may fail to produce Non-Invasive Blood Pressure (NIBP) measurements.

    Product
    Philips Expression MR200 MRI Patient Monitoring System
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0001-2015·2014-10-08

    Invivo Recalls Philips MRI Patient Monitoring Systems Due to Metal Debris

    Invivo is recalling 10 Philips MRI Patient Monitoring Systems because metal debris found during production could cause power failures and loss of patient monitoring.

    Product
    Philips Expression MR200 MRI Patient Monitoring System Model 866120
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2270-2014·2014-08-27

    Invivo Recalls Philips IP5 MRI Patient Monitoring Devices

    Invivo Corporation is recalling 573 Philips IP5 Information Portal devices because a wireless function defect could interrupt communication with the host monitoring system.

    Product
    Philips 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 pro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1096-2014·2014-03-05

    Invivo Expression IP5 Information Portal Recalled for Audio Loss

    Invivo Corporation is recalling 271 Expression IP5 Information Portal devices because three units lost audio during use.

    Product
    Invivo 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 vi
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0983-2014·2014-02-26

    Invivo Expression Information Portal Recalled for Audio Failure

    Invivo Corporation is recalling the Expression Information Portal (Model IP5) because the device may fail to produce audio upon power up.

    Product
    Invivo 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0468-2013·2012-12-12

    Invivo Expression MRI Patient Monitoring System Recalled for Detached Caster Risk

    Invivo Corporation is recalling the Expression MRI Patient Monitoring System because a caster may detach during transport, causing the cart to fall.

    Product
    Invivo 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 sync
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Invivo

Ukrainian medical laboratories chain

Country
Ukraine

Official website

Source: Wikidata (Q121898483), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.