Z-0585-2015 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 31, 2014
- Initiation Date
- November 11, 2014
- Termination Date
- November 24, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- sold in boxes of ten electrodes: 1791.3 boxes; 17913 units total
Product Description
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
Distribution Pattern
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.
Code Information
All Lots. Catalog / Part Number T100LO-PHILIPS