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M SERIES BIPHASIC

Zoll Medical Corporation · Model 60021311100173010 · UDI-DI 00847946014162

DROLLDDPSMKJ
10
510(k) clearances
600
Adverse events (19 deaths)
22
Recalls
23
Facilities

Description

Defibrillator ,MAIN, EMTD-1,BIPHASIC,ETCO2,SPO2,AC,12 LEAD, AUDIO,RC,SMR,CDM, DMST, REFURB

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.