Recall Z-0457-2015 ยท MKJ Automated External Defibrillators (Non-Wearable)
ConMed Corporation
ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
| Date | Dec 4, 2014 (initiated Nov 6, 2014) |
| Status | Terminated |
| Reason | Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury. |
| Root cause | Device Design |
| Action | ConMed sent an Urgent Device Correction letter dated November 16, 2014, to all affected consignees via UPS Next Day Air. The letter instructed consignees to notify all end users of the correction. For questions or additional information, consignees were instructed to contact ConMed at 1-727-399-5276 or by e-mail at multifunctionelectrodes@conmed.com. International notices were sent via UPS Priority or equivalent by November 19, 2014. |
| Quantity | 174,610 (168,090 US and 6,520 OUS) in total. |
| Distribution | Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020203 | PADPRO MODEL #2516 Padpro, LLC, May 8, 2002 |