Reported Apr 13, 2022 · Terminated

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

Remote Diagnostic Technologies Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Remote Diagnostic Technologies Ltd. · PAVILION C2, ASHWOOD PARK · Basingstoke · N/A

Is this the product you have?

    • Tempus LS
    • Type DGE1
    • CAT 00-3010
    • REF 3.940590
    • Software version 1.3.5
  • UDI(01)07613365001693
Lot codes and dates
  • Device Serial Numbers 7021.002073 and 7021.002074
Amount recalled
2

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 25, 2024 · Data as of Sep 19, 7:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.