Invivo Corporation

Complete recall history across all FDA and CPSC categories — 19 total recalls

Invivo Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (19)

FDA medical device enforcement actions by Invivo Corporation

Date Product Reason Class
Sep 14, 2020 MR Coils The MR Coil is intended to be used in conjunction with a Magnetic... The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratin... Class III
Feb 6, 2020 Monitor for the Functional Imaging System for Magnetic Resonance Imaging System Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor. Class II
Sep 24, 2018 Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 The Invasive Blood Pressure (IBP) numeric values will freeze on the display w... Class II
Aug 3, 2018 Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Versio... Released with an incorrect, older firmware version installed. May result in ... Class II
Mar 14, 2018 PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 45356424190... The real-time numeric value for ventricular end-diastolic pressure (EDP) disp... Class II
Jan 24, 2018 DynaCad software consist of an MR Analysis Server software and the viewer wor... Following update from 3.3 to 3.5 of the DynaCAD software it was noted that th... Class II
Nov 20, 2017 Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonito... While in Full Disclosure playback, a user may inadvertently close the Full Di... Class II
Aug 18, 2017 Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive inve... Intermittent communication between the host system and the FlexCardio Class II
Aug 11, 2017 Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitor... Intermittent communication between the host system and the Flex Cardio Class II
May 6, 2016 Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Chan... A diode was inadvertently not assembled into the system, which may result in... Class II
Oct 19, 2015 The system provides the ability to transmit patient data files for storage, v... Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze Class II
Oct 22, 2014 Philips Expression MR200 MRI Patient Monitoring System. The MR 200 devices failed the initial power up test due to capacitor short an... Class II
Sep 14, 2014 Philips Expression Information Portal (IP5) Model 865471. The IP5 is intend... Frozen Display Numerics and Disabled Menu Keys after extended run time. This... Class II
Sep 8, 2014 Philips Expression MR200 MRI Patient Monitoring System Model 866120 During production, excess metal (aluminum) debris was found stuck to the clin... Class II
Sep 5, 2014 Philips Expression MR200 MRI Patient Monitoring System Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement. Class II
Jun 30, 2014 Philips IP5 Information Portal The Expression Information Portal (Model IP... The wireless function of the IP5 radio could be interrupted causing loss of w... Class II
Dec 4, 2013 Invivo Corporation Expression Information Portal (Model IP5) is intended to b... Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is re... Class II
Oct 3, 2013 Invivo Corporation Expression IP5 Information Portal Product Usage: T... Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is re... Class II
Oct 15, 2012 Invivo Corporation Expression MRI Patient Monitoring System. The Expressio... Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is re... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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