Recall Z-1282-2019 ยท MDS Sensor, Glucose, Invasive
Medtronic Inc.
Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
| Date | Jul 4, 2018 |
| Status | Terminated |
| Reason | The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with hypoglycemic or hyperglycemic events. |
| Root cause | Software design |
| Action | A Field Corrective Action was initiated outside of the U.S. by the recalling firm's global regions on 7/4/2018. |
| Quantity | Approximately 9,328 registered users |
| Distribution | Distribution was only made OUS. Countries involved are: Austria, United Arab Emirate, Australia, Belgium, Switzerland, Chile, Colombia, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Hungary, Ireland, Israel, Iceland, Italy, Republic of Korea, Luxembourg, Netherlands, No |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.