Device product
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Z-0861-2022
Product summary
- Event
- Event 89595
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-0861-2022
Official wording
Reason: Distribution of Defibrillators that are not approved or cleared for distribution US Market.
Code information: Device Serial Numbers 7021.002073 and 7021.002074
Distribution pattern: US Nationwide distribution in the states of IL and KS.
Derived failure modes
-
Unknown
Distribution of Defibrillators that are not approved or cleared for distribution US Market.