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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