Reported Sep 26, 2018 · Terminated
Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
Invivo Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Invivo Corporation · 12151 Research Pkwy Ste 200 · Orlando, FL · 32826-3286
Is this the product you have?
- Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
- Lot codes and dates
- System Serial Numbers
US1814000001US1814000002US1814000003US1814000004US1814000006US1814000007US1814000008US1814000011US1814000012US1814000013US1814000014US1814000016US1814000017US1814000018US1814000019US1814000020US1814000022US1814000023US1814000024US1814000027US1814000028US1814000030US1814000031US1814000032US1814000033US1814000034US1814000037US1814000044US1814000046US1814000050US1814000053US1814000062US1814000066US1814000068and US1814000072
- System Serial Numbers
- Amount recalled
- 38
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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