Recall Z-2898-2016— Medtronic Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc., initiated 2016-08-05, terminated 2016-10-20. FDA's recall record names no specific 510(k) clearance for this event. Product: CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.. Reason: Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error..
- Recalling firm
- Medtronic Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-05
- Terminated
- 2016-10-20
- Firm location
- Northridge, CA, United States
Product description
CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.
Reason for recall
Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.
Data sourced from openFDA. This site is unofficial and independent of the FDA.