Recall Z-3192-2018— Invivo Corporation
Class II · Terminated
Class II FDA medical device recall by Invivo Corporation, initiated 2018-08-03, terminated 2021-07-15. It names one FDA 510(k) clearance: K101571. Product: Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388. 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..
- Recalling firm
- Invivo Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-03
- Terminated
- 2021-07-15
- Firm location
- Orlando, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.