Recalls / —
—#131470
Product
PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
- FDA product code
- MKJ — Automated External Defibrillators (Non-Wearable)
- Device class
- Class 3
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K020288
- Affected lot / code info
- All Lot Codes
Why it was recalled
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 (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- ConMed Corporation
- Address
- 525 French Rd, Utica, New York 13502-5945
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2014-11-06
- Posted by FDA
- 2014-12-04
- Terminated
- 2017-10-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #131470. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.