Device product

Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A

Z-0048-2015

September 18, 2014

Class I

Product summary

Firm: Covidien LLC
Event: Event 69257
Status: Terminated
Classification: Class I
Quantity: 151,210 pairs
Official record key: device-enforcement:Z-0048-2015

Official wording

Reason: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs

Code information: Al lot codes

Distribution pattern: Worldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Chile Philippines Taiwan Australia New Zealand.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs