Safety Alert for Trade name: RADspeed. Technical Name: Fixed X-ray Apparatus ANVISA registration number: 10369010053. Hazard class: III. Affected template: RADspeed, RADspeed MC and RADspeed MF. Serial numbers affected: 3ZC5C1039012; 3ZC5C1029007; 3ZC5C1029008; O262M44605; 3ZC5C1016010; 3ZC5C2716006; 0562M40110; 3ZC5C1018006; 3ZC5C1033012; 3ZC5C2717001; 3ZC5C2721008; 0462M4978; 3ZC5C1057016; 3ZC5C1047008; 3ZC5C2715004; 056M45507; 0562M45508; 3ZC5C1049012; 0562M41102; 0562M41103; 0462M41408; 3ZC5C2722009; M1E733867004, 3ZC5C2722010, 3ZC5C2721009, 0562M46010, 3ZC5C1057022, M1E733B66012

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Shimadzu do Brasil Comércio Ltda; Shimadzu Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2331
  • Date
    2017-07-05
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • Notes / Alerts
    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.
  • Extra notes in the data
    After the action, the product can be operated normally without recommendation. Prior to the Field Action, a letter will be sent alerting customers of this possibility and requesting that they be aware of any abnormality in the movement of the rooftop until the field action is completed. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. 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: 05/15/2017 - Date of notification notice to Anvisa: 05/07/2017 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. (...) "
  • Reason
    In equipment combined with a model ch-200 / 200m ceiling unit, the x-ray tube is mounted or fixed through a phalanx, which is part of the duct / arm that supports the whole of x-ray. it has been found that, very rarely, cracks may occur over time of the duct / spleen supporting the x-ray tube near this phalanx. if these cracks occur and then increase in size, the phalanx that supports the x-ray tube may separate from the duct / arm. our investigations have determined that there is little chance that the x-ray tube will move out of the required perimeter and contact the operator or even the patient if it is close to the tube.
  • Action
    Field Action Code 0003/2017 triggered under the responsibility of Shimadzu do Brasil Comércio Ltda. Correction of parts.

Manufacturer