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Tempus LS-MANUAL

Schiller AG · Model 3.940589 · UDI-DI 07613365002737

DRODPSLIXLDD Prescription
1
510(k) clearances
599
Adverse events (19 deaths)
22
Recalls
23
Facilities

Description

The TEMPUS LS – MANUAL is a multi-function, portable device that is capable of providing defibrillation therapy, non-invasive external pacing, displaying ECG, and CPR feedback in hospital and pre-hospital settings.

Recalls

DateFirmReason
2020-03-10Smiths Medical ASD Inc.Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
2020-03-10Smiths Medical ASD Inc.Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
2020-03-10Smiths Medical ASD Inc.Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
2020-03-10Smiths Medical ASD Inc.Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
2020-03-10Smiths Medical ASD Inc.Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
2020-03-10Smiths Medical ASD Inc.Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
2020-03-10Smiths Medical ASD Inc.Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
2020-03-10Smiths Medical ASD Inc.Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
2020-03-10Smiths Medical ASD Inc.Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
2020-03-10Smiths Medical ASD Inc.Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.