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.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (inaccurate medical monitoring) where specific injuries or illnesses have not yet been reported.
Plain-English summary
Invivo Corporation is recalling 38 units of the Xper Flex Cardio Physiomonitoring System, Model # 453564669081, Software Version 1.6.0.0388. The affected units were distributed in the Netherlands and are identified by specific serial numbers listed in the recall notice.
The recall was initiated because the devices were released with an incorrect, older firmware version installed. This software error may result in intermittent loss of ECG monitoring, inaccurate ECG amplitude display or auxiliary output, and inaccurate heart rate displays due to a QRS detection fault.
Healthcare facilities and users should stop using the affected devices and contact Invivo Corporation for further instructions on the recall.
The recalled product
- Product
- Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
- Manufacturer
- Invivo Corporation
- Affected units
- 38
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- System Serial Numbers: US1814000001
- US1814000002
- US1814000003
- US1814000004
- US1814000006
- US1814000007
- US1814000008
- US1814000011
- US1814000012
- US1814000013
- US1814000014
- US1814000016
- US1814000017
- US1814000018
- US1814000019
- US1814000020
- US1814000022
- US1814000023
- US1814000024
- US1814000027
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Invivo Corporation
See all →- LowInvivo MR Coils Recalled for Incorrect IPX1 Water Ingress Rating Label
FDA (Devices) · 2020-10-28
- HighInvivo Recalls MRI Monitor Adapters Due to Insufficient Shielding
FDA (Devices) · 2020-03-11
- HighInvivo Xper Flex Cardio Physiomonitoring System Software Recall
FDA (Devices) · 2018-11-21
- ModerateInvivo Xper Flex Cardio Physiomonitoring System Recalled for Software Defect
FDA (Devices) · 2018-06-13
- HighInvivo Xper Flex Cardio Physiomonitoring System Recalled for Inaccurate Pressure Readings
FDA (Devices) · 2018-05-23
Same hazard · software defect
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- HighTandem t:slim iOS App Recall Due to CGM Pairing Failure
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighInvivo Xper Flex Cardio Physiomonitoring System Software Recall
FDA (Devices) · 2018-11-21
- ModerateInvivo Recalls Xper Flex Cardio PhysioMonitoring Systems Due to Communication Errors
FDA (Devices) · 2017-11-15
- HighPhilips Xper Flex Cardio Physiomonitoring System Recalled for Display Errors
FDA (Devices) · 2018-12-26
- ModerateInvivo Recalls Xper Flex Cardio Physiomonitoring Systems Due to Communication Issues
FDA (Devices) · 2017-12-27
- HighInvivo Xper Flex Cardio Physiomonitoring System Recalled for Inaccurate Pressure Readings
FDA (Devices) · 2018-05-23
- ModerateInvivo Xper Flex Cardio Physiomonitoring System Recalled for Software Defect
FDA (Devices) · 2018-06-13