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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1189-2013

HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.

Publicado el 8 de mayo de 2013 · Inicio del retiro: 8 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

Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Philips Healthcare Inc.
Distribuidor
Worldwide distribution: USA (nationwide) and countries of: Afghanistan, Albania, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegowina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cambodia, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic Of, Kuwait, Laos, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Malta, Mexico, Mongolia, Morocco, Namibia, Nepal, Netherlands (Antilles), New Caledonia, New Zealand, Nicaragua, Nigera, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Puerto, Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, SRI Lanka, Sweden, Switzerland, Taiwan (Province of China), Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Veit Nam, and Yemen.
Lote
Serial numbers ranging from US00100100 to US00565942 Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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