Xper Flex Cardio Physiomonitoring System recall
Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
Why was Xper Flex Cardio Physiomonitoring System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
- Recalling firm
- Invivo Corporation
- Quantity
- 38
- Distribution
- Distribution in the Netherlands
- Recall date
- September 26, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)