Recall Z-0670-2018 ยท OZO Automated Insulin Dosing , Threshold Suspend
Medtronic Inc.
Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be used by a healthcare professional (HCP) with the iPro2 CGM System and provides upload support for the iPro2 Recorder. The CareLink iPro software is used to upload glucose sensor data stored on a recording device, capture BG meter readings through manual e
| Date | Oct 10, 2017 |
| Status | Terminated |
| Reason | Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro software using the new CareLink iPro Uploader feature may result in incorrect reports. This pertains only to reports generated between September 23, 2017 and September 27, 2017 that used the new CareLink iPro Uploader feature. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | A communication is being sent to all healthcare professionals who had uploaded reports using the universal uploader feature between September 23, 2017 to September 27, 2017. The method is by mail and by email, with a response requested from the healthcare professional to confirm they have received and read the notice. For further questions please call (877) 874-7717 |
| Quantity | 488 uploads |
| Distribution | Worldwide Distribution - US Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.