Device recall: Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388

Class II FDA enforcement event 81092. Recall start date: 24 Sep 2018. Status in the FDA record: Completed.

Reason for recall, in the words of FDA

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…

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Invivo Corporation started this device recall on 24 Sep 2018. The firm address in the FDA record is in Orlando, FL. FDA put the recall in Class II. FDA event 81092 has 1 product record. The first FDA enforcement report date is 21 Nov 2018. The record gives the status Completed.

FDA enforcement report The 1 product record

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 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Distributed to the Netherlands

Recalling firm

Invivo Corporation, Orlando, FL.

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

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 81092: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0462-2019	Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388	76 units	Class II	Completed	21 Nov 2018

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.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

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

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2018: 1,074
Share of these events in Class II: 92%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 19

Other events of the firm

Other FDA enforcement events of Invivo Corporation
Initiated	Product (first record)	Type	Class	Records
14 Sep 2020	MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic image	Device	Class III	1
6 Feb 2020	Monitor for the Functional Imaging System for Magnetic Resonance Imaging System	Device	Class II	1
3 Aug 2018	Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388	Device	Class II	1
14 Mar 2018	PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199	Device	Class II	1
24 Jan 2018	DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software	Device	Class II	1
20 Nov 2017	Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive inv	Device	Class II	1
18 Aug 2017	Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when	Device	Class II	1
11 Aug 2017	Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to facilitate invasive inv	Device	Class II	1
6 May 2016	Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.	Device	Class II	1
19 Oct 2015	The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed location	Device	Class II	1

Invivo Corporation: all 19 events

Official channels

FDA enforcement report Z-0462-2019The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 81092. https://recallregister.com/fda/ii/81092/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Distributed to the Netherlands
What quantity of product is in FDA event 81092?: The FDA record gives this quantity: 76 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2018 have the same class?: 92% of the 1,074 device events that started in 2018 are in Class II.