Z-1582-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- June 27, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30,479
Product Description
MiniMed Paradigm Model 511 Insulin Pump
Reason for Recall
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.
Distribution Pattern
US nationwide distribution including Puerto Rico.
Code Information
All Software Versions