Alerte De Sécurité sur Commercial Name: X-ray Apparatus. Technical Name: Fixed X-ray Apparatus. ANVISA registration number: 10216710166. Risk Class: III. Model Affected: OmniDiagnost Elevates. Serial numbers affected: 317

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Philips Medical Systems Ltda; Philips Medical Systems DMC GmbH.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
  • Date
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    Recommendations (what to do, contacts with the manufacturer, how to notify Anvisa, etc.): The company recommends users that if any of the following occur, stop using the system and call the Philips representative: • lift movement and slope do not work. • if you hear a different click from normal sounds during hoist or tilt movement. • if you notice a blockage in the lifting or tilting movement during system movements. • the system is crashing accidentally, or has been in the past two months. • a CPR holder has been used that has obstructed the system; or • has noticed any (unusual) behavior of the system, at odds with its normal use. Also, it is recommended that you avoid collisions with the table or the support platform of the system, ensuring that there is no obstacle around the system. It informs the need for the customer to ensure that all employees who have access to affected systems become aware of the contents of this Security Notice. Put a copy of the Safety Notice together with the system documentation until it has been repaired by Philips. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 01/05/2018 - Date of notification notice to Anvisa: 05/08/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Cause
    According to the company, the omnidiagnost system's upper and lower tilt actuator attachment can come off and the table begins to rotate from 0 to + 90 / -90 degrees at high speed. this rotating movement can not be interrupted by the user. if there is uncontrolled rotation, there is a risk of injury to the patient, the users or third parties that are close to the system (the tube can reach people's legs, for example). this can cause injuries that will require medical intervention for the person involved.
  • Action
    Field Action Code FCO70800153 under the responsibility of Philips Medical Systems Ltda. Field Correction. Parts / parts correction.


  • Société-mère du fabricant (2017)
  • Source