Orlando, FL, United States
Invivo Corporation recalls
7 recalls recorded since 2018, most recently on 14 September 2020. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)1
Terminated or completed6
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 14 September 2020
- Terminated
- 14 August 2023
- Reason
- The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress.
- Distribution
- US Nationwide Distribution: AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OK, OH, PA, PR, RI, SC, TN, TX, VA, VT, WA, WI, and WV; and the countries of: Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Banglade
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0126-2021
- 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.
Terminated Class II Medical devices
- Recall started
- 6 February 2020
- Terminated
- 4 May 2022
- Reason
- Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.
- Distribution
- U.S Distribution: AK, AL, CA, CO, FL, IL, IN, KY, MA, MI, NY, OH, OR, PA, TN, TX and WV. *** Foreign: Australia, Canada, France, United Kingdom, Italy, Japan, Netherlands, Saudi Arabia, India and Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1440-2020
- Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
Completed Class II Medical devices
- Recall started
- 24 September 2018
- 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 the mean pressure waveform display option (On/Off) using the Invasive Pressure Options Dialog or the keyboard, activate or deactivate the waveform hide option (On/Off) using the Invasive Pressure Options Dialog, activate or deactivate the pressure waveform filter option (On/Off) using the keyboard, and/or perform a Pullback using the Pullback icon or the keyboard
- Distribution
- Distributed to the Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0462-2019
- Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
Terminated Class II Medical devices
- Recall started
- 3 August 2018
- Terminated
- 15 July 2021
- 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 QRS detection fault.
- Distribution
- Distribution in the Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3192-2018
- Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
Terminated Class II Medical devices
- Recall started
- 14 March 2018
- Terminated
- 30 April 2021
- 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 procedure room using the FC2010 device, the FC2020 device, which is used in the Pre or Post-Op Holding Areas, is not impacted by this issue.
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico., and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Cyprus, Egypt, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Italy, Kazakhstan, K
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1867-2018
- 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 invasi
Terminated Class II Medical devices
- Recall started
- 24 January 2018
- Terminated
- 4 May 2020
- 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 when viewed from remote DynaCAD client computers and could result in visually underestimating calculated Ktrans, Kep, and iAUGC values. The defect also impacts DynaCAD s on-the-fly calculation of Apparent Diffusion Coefficient (ADC) maps. If the ADC values are computed on-the-fly by DynaCAD, the ADC values and colors will also display incorrectly if viewed on a remote DynaCAD client.
- Distribution
- Device is software. Customer notification letters recommended that users discontinue use of the Ktrans, Kep, and iAUGC colormaps when assessing studies from a remotely connected DynaCAD client computer. It is further advised that users refrain from using the colormaps and values derived from ADC ma
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1289-2018
- 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 module
Ongoing Class II Medical devices
- Recall started
- 20 November 2017
- 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.
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, NV, OH, PA, RI, SC, TN, TX, VA, WA, and WI ; and countries of: Canada, China, Great Britain and Korea.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2115-2018
- 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 Fl
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.