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ONESTEP PEDIARIC CPR MULTI-FUNCTION ELECTRODE, SIN
Zoll Medical Corporation · Model 8900-000231-01 · UDI-DI 00847946099640
10
510(k) clearances
153
Adverse events (2 deaths)
2
Recalls
17
Facilities
Description
ONESTEP CPR II MULTI-FUNCTION ELECTRODE, SINGLE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-01-29 | Philips Electronics North America Corporation | Inform 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 |
| 2018-01-29 | Philips Electronics North America Corporation | Inform 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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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.