FDAFDA · Alimentos y medicamentos·N.º oficial Z-1604-2018
708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
Publicado el 9 de mayo de 2018 · Inicio del retiro: 26 de marzo de 2018
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
The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Philips Medical Systems Nederlands
- Distribuidor
- Worldwide Distribution: US (Nationwide) and countries of: Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Farce Islands, Finland, France, Germany, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Korea, Republic of, Latvia, Lebanon, Luxembourg, Malaysia, Martinique Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
- Lote
- System Serial # 8 14 1 64 15 4 3 7 18 48 16 2 59 60 17 11 13 21 5
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Netherlands
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.