Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies.
Publicado el 5 de junio de 2013 · Inicio del retiro: 26 de abril de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- Heart Sync, Inc
- Distribuidor
- Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea.
- Lote
- Part Number: D304 and lot numbers:Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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