Electrode, Electrocardiograph, Multi-Function
FDA product code MLN · Class II (moderate risk) · 21 CFR 870.2360 · Cardiovascular
0510(k) clearances
0PMA approvals
8recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0856-2012 | R2 Adult R2 Non-Radiolucent Multifunction Electrodes, Catalog/REF No. 3200-1715…The specific lot was assembled without the rivet cover. | ConMed Corporation | 03/31/2011Terminated |
| Z-1372-2011 | Medstorm Adult Radiolucent Zoll Medical (Part # 16381, HeartSync, Ann Arbor, MI. The…The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package… | Heart Sync, Inc | 12/17/2010Terminated |
| Z-1371-2011 | Medstorm Adult Radiolucent Electrode Philips Medical , Part #16250, HeartSync Ann Arbor…The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package… | Heart Sync, Inc | 12/17/2010Terminated |
| Z-1951-2011 | Heart Sync Adult Radiolucent Electrode -Physio Control, Part T100LO-PHYSIO. Indicated…The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control… | Heart Sync, Inc | 12/05/2008Terminated |
| Z-1950-2011 | Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. Indicated…The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control… | Heart Sync, Inc | 12/05/2008Terminated |
| Z-2334-2008 | ZOLL OneStep Multi-Function Electrode; Adult Complete Part #: 8900-0214-01. The…Multi-function electrode programmed as a Pediatric instead of Adult | Bio-Detek, Inc. | 06/16/2008Terminated |
| Z-0757-2007 | PADPRO ADULT Radiotranslucent Pad w/Medtronic connector, REF/Catalog #2516M. RX ONLY.…Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an… | Conmed Corporation | 03/08/2007Terminated |
| Z-0756-2007 | PADPRO ADULT Radiotranslucent Pad w/Zoll connector. Defibrillation/Pacing/Cardioversion/M…Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an… | Conmed Corporation | 03/08/2007Terminated |