Safety Alert for Commercial Name: Optima Magnetic Resonance Imaging System. Technical Name: Magnetic Resonance Equipment. ANVISA registration number: 80071260300. Risk Class: II. Model affected: OPTIMA MR450w GEM. Serial numbers affected: 00000014131M67; 00000018480M64; 00000021158M61. All "MR Surgical Suite" tables that use mobile patient transfer plate between the GE table (model M0074SS) and the Surgical Magnus Maquet table with 1150 or 1180 table tops.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE MEDICAL SYSTEMS LLC.

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.

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  • Type of Event
    Safety alert
  • Event ID
  • Date
  • Event Country
  • Event Source
  • 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
    Recommendations (what to do, contacts with the manufacturer, how to notify Anvisa, etc.): Through the Urgent Security Notice Letter, users will be informed that the "MR Surgical Suite Table" table may continue to be used, , however, refer to the Operator's Manual for detailed descriptions of the various safety interlocks and operating mechanisms. They will also be advised to monitor any problems in releasing the transfer board from the Surgical MR GE table, and should contact the field engineer of the company holding the registration if they encounter any problems. They will also be instructed to test all patient transfer features as described in the Urgent Safety Notice Letter as part of a quality check before each procedure. 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: 10/20/2017 - 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. (...) "
  • Reason
    The company received complaints that the mr surgical suite table was not released and could prevent the transfer of the patient to the "surgical magnus maquet" table. there were no injuries reported as a result of this problem.
  • Action
    Field Action IMF Code 60933 under the responsibility of GE Healthcare do Brasil, Com. E Serv. for Equipos Médico-Hospitalares Ltda. Field correction. Updating, correcting or supplementing the instructions for use. Parts / parts correction.