FDA Device recall Z-0802-2015

GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes

• FDA Device
• Class I
• terminated
• Published 2014-12-31

On 2014-12-31 the FDA classified a Class I recall of GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes by Leonhard Lang, citing the firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. This could lead to a situation, in which a….

Read the official FDA Device notice

Product

GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: Usage: Skintact Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only.

Reason

The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. This could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0802-2015%22

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