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Remote Diagnostic Technologies Ltd. recalls Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Recalled April 13, 2022 · FDA recall Z-0861-2022 · Remote Diagnostic Technologies
Hazard
Distribution of Defibrillators that are not approved or cleared for distribution US Market. · FDA Class II
Units
2
Sold at
US Nationwide distribution in the states of IL and KS.
Description
Distribution of Defibrillators that are not approved or cleared for distribution US Market.
Product
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Manufacturer(s)
Remote Diagnostic Technologies Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →