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M SERIES BIPHASIC

Zoll Medical Corporation · Model 60021311100103010 · UDI-DI 00847946014124

DROLLDMKJDPS
10
510(k) clearances
599
Adverse events (19 deaths)
22
Recalls
23
Facilities

Description

Defibrillator ,MAIN, BASIC-4, 12LEAD,ETCO2,SPO2,BIPHASIC,AC,PC,EL,RC,SM,CM,ENG,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.