Adult Radiotransparent Electrode, Pediatric Radiotranslucent Electrode and Mini Pediatric Radiotranslucent Electrode (2014-11-18)

Starting date:

November 18, 2014

Posting date:

November 28, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-42663

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  Reason
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  Affected products

Recalled Products

A) Adult Radiotransparent Electrode

B) Pediatric Radiotranslucent Electrode and Mini Pediatric Radiotranslucent Electrode

Reason

Philips healthcare has made changes to the design of the connection between multifunction electrodes and their Heartstart FR3 and Heartstart FRX AEDs. Because of this change, ConMed's multifunction electrodes listed above will not connect to these AEDs. The Heartstart 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 Heartstart FR3 however, does not require pre-connection and the user will not discover the compatibility issue until the AED must be used. In this circumstance the failure to connect may result in a delay of therapy, which could result in patient death or serious injury. ConMed's PadPro and R2 devices still work with other Phillips AEDs which accept plug style connectors. Philips Healthcare Heartstart FR3 and Heartstart FRX AED units should only be used with the Philips brand electrodes specified in the Philips medical equipment manuals. ConMed's labeling has been updated accordingly.

Affected products