Recall Z-2980-2020 ยท MDS Sensor, Glucose, Invasive
Medtronic Inc.
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
| Date | Jul 15, 2020 |
| Status | Terminated |
| Reason | As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to the website. |
| Root cause | Software design |
| Action | On July 15, 2020, the firm sent an "URGENT FIELD SAFETY NOTIFICATION" to customers/Care Partners/Healthcare Professionals via email informing them that the Recalling Firm released an update to the CareLink Personal Software. Following the release of the software, several customer using the iOS app experienced data connectivity disruptions and as a result: 1. Care partners may not receive SMS alerts 2. Care partners remote access monitoring in the CareLink Connect web app may show data gaps 3. Customers may see data gaps in their reports. Customer are instructed to: 1. Attempt to manually upl |
| Quantity | 3,588 users |
| Distribution | International distribution including in the countries of EMEA - Austria, Belgium, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Kuwait, Latvia, Luxembourg, The Netherlands, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Sl |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.