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Intellisense Adult Defibrillation Pads,CPR Device, Powerheart® G5

Zoll Medical Corporation · Model XELAED002A · UDI-DI 00812394020966

LIX Prescription
10
510(k) clearances
153
Adverse events (2 deaths)
2
Recalls
17
Facilities

Description

Intellisense Adult defibrillation Pads, non-polarized, with CPR Feedback Device for Powerheart® G5

Recalls

DateFirmReason
2018-01-29Philips Electronics North America CorporationInform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consent
2018-01-29Philips Electronics North America CorporationInform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consent

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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.