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.
What this means for you
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.
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