Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
Reported: September 26, 2018 Initiated: August 3, 2018 #Z-3192-2018
Product Description
Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
Reason for Recall
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.
Details
- Recalling Firm
- Invivo Corporation
- Units Affected
- 38
- Distribution
- Distribution in the Netherlands
- Location
- Orlando, FL
Frequently Asked Questions
What product was recalled? ▼
Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388. Recalled by Invivo Corporation. Units affected: 38.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 26, 2018. Severity: Moderate. Recall number: Z-3192-2018.
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