Device product
Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
Z-1592-2020
Product summary
- Event
- Event 83433
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 27
- Official record key
device-enforcement:Z-1592-2020
Official wording
Reason: The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.
Code information: All software versions 2.4A or lower
Distribution pattern: US nationwide distribution including Puerto Rico.
Derived failure modes
-
Device software or design
cybersecurity vulnerabilities