CLASS I Device recall · Reported 10 Dec 2014 · FDA Enforcement Report

Mini Pediatric Radiotransparent Electrode recalled by ConMed

ConMed is recalling Mini Pediatric Radiotransparent Electrode, distributed nationwide in the US. The recall was initiated on 6 Nov 2014 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll Lot Codes

Quantity recalled174,610 (168,090 US and 6,520 OUS) in total.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0460-2015
FDA event ID: 69752
Recalling firm: ConMed, Utica, NY
Classification: Class I
Status: Terminated
Recall initiated: 6 Nov 2014
FDA classified: 4 Dec 2014
Reported: 10 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

6 Nov 2014	Recall initiated by company
4 Dec 2014	Classified by FDA	+28 days
10 Dec 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR--Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Is Mini Pediatric Radiotransparent Electrode recalled?

Yes. ConMed recalled Mini Pediatric Radiotransparent Electrode on 6 Nov 2014. The recall is Class I and its status is Terminated. Recall number Z-0460-2015.

Why was it recalled?

Which lots are affected?

All Lot Codes

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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