Reported Dec 27, 2017 · Terminated
Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when…
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. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.
- Lot codes and dates
- All Flex Cardio devices, Revision A
- B Code Number's
4535642419014535642419114535644833214535644833319898031856019898031930191860335 and 860338
- Amount recalled
- 4,535
Where it was sold
Why it was recalled
Intermittent communication between the host system and the FlexCardio
This product could cause temporary or reversible health problems — stop using it.
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