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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
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
A) Adult Radiotransparent Electrode
Lot or serial number
All lots.
Model or catalog number
2001H
2001H-C
2001H-PC
2516H
2516H-PC
Companies
- Manufacturer
-
Conmed Corporation
525 French Road
Utica
13502
New York
UNITED STATES
B) Pediatric Radiotranslucent Electrode and Mini Pediatric Radiotranslucent Electrode
Lot or serial number
All lots.
Model or catalog number
2602H
2603H
Companies
- Manufacturer
-
Conmed Corporation
525 French Road
Utica
13502
New York
UNITED STATES