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FDAJanuary 28, 2022device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

remote diagnostic technologiesremoteremote diagnostic

UPCs

07613365001693

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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