Xper Flex Cardio PhysioMonitoring system The Xper Flex recall
Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and…
Why was Xper Flex Cardio PhysioMonitoring system The Xper Flex recalled?
Intermittent communication between the host system and the Flex Cardio
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?
Model 453564621791 and 453564621801 - ALL Flex Cardio Devices, Revision C
- Product
- Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and…
- Recalling firm
- Invivo Corporation
- Quantity
- 529
- Distribution
- Worldwide Distribution - US including AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, KY, LA, MA, MI, MO, NC, NE, NM, NY, OH, OR, OK, PA, SD, TN, TX, VA, WA, WV and Internationally to Germany, Hungary, India, Netherlands, Russia, Saudi Arabia, South Africa and Tunisia.
- Recall date
- November 15, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)