FDAFDA · Alimentos y medicamentos·N.º oficial Z-1776-2025
Intera 1.5T Master/Nova, Model Number: 781106;
Publicado el 21 de mayo de 2025 · Inicio del retiro: 24 de marzo de 2025
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Distribuidor
- US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zambia.
- Lote
- Model Number (REF): 781106; UDI-DI: N/A; All serial numbers.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Netherlands
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