Z-1258-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 22, 2022
- Initiation Date
- September 10, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,206
Product Description
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Reason for Recall
Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.
Distribution Pattern
International distribution in the country of Australia.
Code Information
Dexcom G5 - All Serial Numbers; Basal-IQ Technology - Software Versions 6.3.01 and Earlier