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M SERIES BIPHASIC

Zoll Medical Corporation · Model 40021321100063010 · UDI-DI 00847946005672

LLDDPSDROMKJ
4
510(k) clearances
16
Adverse events
6
Recalls
2
Facilities

Description

Defibrillator ,MAIN,EMTD-2,12 LEAD,SPO2,ETCO2,BIPHASIC,EL,RCD,SMR,CDMK,DC,DMST

Recalls

DateFirmReason
2005-06-08Boston Scientific CorporationPotential for port housing separation after implantation.
2005-06-08Boston Scientific CorporationPotential for port housing separation after implantation.
2005-06-08Boston Scientific CorporationPotential for port housing separation after implantation.
2005-02-25Boston Scientific CorporationPotential separation of the port base from the port cover after implantation.
2005-02-25Boston Scientific CorporationPotential separation of the port base from the port cover after implantation.
2005-02-25Boston Scientific CorporationPotential separation of the port base from the port cover after implantation.

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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.