FDA recall Z-0861-2022

Remote Diagnostic Technologies Ltd. · Class II · device

Product

Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693

Reason for recall

Distribution of Defibrillators that are not approved or cleared for distribution US Market.

Distribution

US Nationwide distribution in the states of IL and KS.

Key facts

Status
Terminated
Initiation date
2022-01-28
Report date
2022-04-13
Termination date
2024-07-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Basingstoke, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0861-2022