FDA Device recall Z-1501-2016
CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuou…
- FDA Device
- Class II
- terminated
- Published 2016-04-27
On 2016-04-27 the FDA classified a Class II recall of CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuou… by Medtronic Minimed, citing medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports were created using the Pacific Standard Time zone as the time referenc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1501-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-19 |
| Published | 2016-04-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Minimed |
| Distribution | MN |
Product
CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information
Reason
Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports were created using the Pacific Standard Time zone as the time reference, although the patients and their sensor data were subject to the Central Standard Time zone. The CareLink iPro2 Professional CGM (continuous glucose monitor) data uploading error that resulted in an inaccurate time zone being applied to 19 CareLink iPro reports.
Identifiers
| code_info | n/a |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1501-2016%22
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