Heart Sync, Inc. Recall: ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx
Heart Sync, Inc. Recall: ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Heart Sync, Inc.; Product: ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to
| Recalling firm | Heart Sync, Inc. |
|---|---|
| Product | ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use. |
| Reason for recall | Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user may not discover the incompatibility issue until the |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| Distribution | Worldwide Distribution - USA (Nationwide) in the states of NM, VT, MN, IL, MO, OH, MI, OR, ND, KY, PA, TX, WA, FL, NE, AR, VA, DE, GA, NY, CA, TN, AZ, RI, MA, and PR; and countries of: Thailand and South Korea. |
| Recall initiated | 20141111 |
| Recall number | Z-0585-2015 |
| Category | device |
| State | MI |
| Country | United States |
$29/mo
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