Z-3192-2018 Class II Terminated
FDA device recall Z-3192-2018 was initiated by Invivo Corporation on August 3, 2018 and is designated Class II. 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 (H… The recall status is terminated (terminated July 15, 2021). Affected quantity: 38.
Recall Details
- Product Type
- Devices
- Report Date
- September 26, 2018
- Initiation Date
- August 3, 2018
- Termination Date
- July 15, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38
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.
Distribution Pattern
Distribution in the Netherlands
Code Information
System Serial Numbers: US1814000001, US1814000002, US1814000003, US1814000004, US1814000006, US1814000007, US1814000008, US1814000011, US1814000012, US1814000013, US1814000014, US1814000016, US1814000017, US1814000018, US1814000019, US1814000020, US1814000022, US1814000023, US1814000024, US1814000027, US1814000028, US1814000030, US1814000031, US1814000032, US1814000033, US1814000034, US1814000037, US1814000044, US1814000046, US1814000050, US1814000053, US1814000062, US1814000066, US1814000068,and US1814000072