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M SERIES BIPHASIC
Zoll Medical Corporation · Model 40021311100123010 · UDI-DI 00847946005573
4
510(k) clearances
16
Adverse events
6
Recalls
2
Facilities
Description
Defibrillator ,MAIN MANUAL 1,12LEAD,ETCO2/SPO2,AC,BIPHASIC,PACE,EL,RCD,SMR,CDMK,ENG
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2005-06-08 | Boston Scientific Corporation | Potential for port housing separation after implantation. |
| 2005-06-08 | Boston Scientific Corporation | Potential for port housing separation after implantation. |
| 2005-06-08 | Boston Scientific Corporation | Potential for port housing separation after implantation. |
| 2005-02-25 | Boston Scientific Corporation | Potential separation of the port base from the port cover after implantation. |
| 2005-02-25 | Boston Scientific Corporation | Potential separation of the port base from the port cover after implantation. |
| 2005-02-25 | Boston Scientific Corporation | Potential separation of the port base from the port cover after implantation. |
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Get your free API keyRead the docsData 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.