Alerte De Sécurité sur Commercial Name: Computed Tomography System / CT Scanner. Technical Name: Computerized Tomographic Equipment. ANVISA registration number: 80071260079. Risk Class: III. Affected Model: Optima CT 540, BRIGHTSPEED ELITE 16 SLICE EDITION, Optima CT 540 Mobile, OPTIMA CT 660, REVOLUTION EVO, Optima CT 660 Cj 3.5 (80071260119 and 80071260079). Serial numbers affected: CJRAX1600072CN; CJRAX1700001CN; CJRAX1700002CN; CJRMX1600005CN; JRMX1600011CN; CJRMX1600012CN; CJRMX1600013CN; CJRMX1600014CN; CJRMX1600018CN; CJRMX1600019CN; 00000030120YC0; 00000030500YC3; 00000033404YC5; 00000033973YC9; 00000035290YC6; 00000428317CN2; 00000429355CN1; 00000429530CN9; 00000437168CN8; 00000437278CN5; 00000441652CN5; 00000441968CN5; CBAQG1600010HM.

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 GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE HEALTHCARE JAPAN CORPORATION; GE HEALTHCARE DO BRASIL COM. E SERV. P/ EQUIP. MÉDICO-HOSPITALARES LTDA.; GE MEDICAL SYSTEMS LLC.; GE HANGWEI MEDICAL SYSTEMS CO, LTD..

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
    Make sure that the organization that serves your CT scanning system is aware of this potential risk and wear protective gloves when using the wheel rims on the cover until GE Healthcare can correct it. The company states that there is no risk to its patients or to its CT Operators / technicians, only to field engineers capable of performing internal equipment maintenance. It states that customers can continue to use their system while waiting for this fix. All affected systems will be inspected as part of this Field Action. The inspection will include verification of damage to the cable and proper routing of cables. Those systems that have damage to the cable will receive a replacement. 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 - Date of identification of the problem by the company: 04/26/2018 - Date of notification notice to Anvisa: 05/11/2018 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
    The registrant has identified that some ct scanning systems may have damaged cable, which may expose 120 vac to maintenance engineers working with the equipment. it states that this problem does not affect patients or operators outside the equipment. when the front cover of the gantry is removed for the maintenance of components within the gantry, platforms on the cap wheels are used to handle the cap. during the removal or replacement of the front cover, the stand may come in contact with the internal power cable and may damage the insulation of that cable. this may expose the conductor of the 120 vac power cord and electrify the wheel's deck on the cover, thereby introducing the risk of electric shock to maintenance personnel.
  • Action
    Field Action IMF Code 26859 under the responsibility of GE Healthcare do Brasil, Com. for Equipos Médico-Hospitalares Ltda. Field Correction. Parts / parts correction.