Recall Z-0584-2015
Heart Sync, Inc. · initiated November 11, 2014
Class I – dangerous or defective products that could cause serious health problems or death
Product
ADULT/CHILD Radiotransparent Electrode, Part number C100AC-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.
Codes / lots: All Lots. Catalog / Part Number C100AC-PHILIPS
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
FDA-determined cause: Device Design
Action taken
The firm, HeartSync, sent an "Voluntary Field Safety Alert for Heart Sync Multi-function Defibrillator Electrodes" notice dated 11/11/2014 to customers via email notifying them of the incompatibility with the Philips FR3 and FRX AEDs and requesting response to the notice. On 12/1/2014 (dated 11/26/2014) Heart Sync issued a Voluntary Device Correction via Press Release. The Press Release included a description of the reason for the recall, affected product, and instruction that the Philips FR3 and FRx AED units should only be used with electrodes specified in the (Philips) equipment manuals. For further information or to report a problem, please contact Heart Sync at 734-213-5530, 24 hours a day, 7 days a week, ,or email at Jahana@heartsync.net.
Details
- Recall number
- Z-0584-2015
- Initiated
- November 11, 2014
- Posted by FDA
- December 24, 2014
- Terminated
- November 24, 2015
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- sold in boxes of ten electrodes: 116 boxes; 1160 units total
- 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.
- Recalling firm
- Heart Sync, Inc., Ann Arbor, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0583-2015 Class I | ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with…Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The… | 11/11/2014Terminated |
| Z-0585-2015 Class I | ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with…Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The… | 11/11/2014Terminated |
| Z-0586-2015 Class I | ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with…Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The… | 11/11/2014Terminated |
| Z-0587-2015 Class I | ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use…Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The… | 11/11/2014Terminated |