Events

Safety Alert for Magnetic Resonance Imaging Equipment INTERA / ACHIEVA; risk class II, records: 10216710194; 10216710205; series / lots affected see ANNEX.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V/ Philips Medical Systems Ltda..

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
    1627
  • Date
    2015-07-03
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    According to the information of the holder, unplanned resonances of the patient or the elevated temperature of the coil cable can occur when the cables are placed in either of the tracks, each one contrary to the Instructions for Use: • Coil cables are placed in circles or twisted within the QBC (RF area); // • Coil cables do not work directly away from the region of interest // Coil cables are directed close to QBC // Coil cables are in direct contact with the patient's body // The interface box of the coil is in direct contact with the patient's body; // or • Coil and interface box cables do not have enough distance between them. //// Combined use of the SENSE coil, high specific absorption rate (SAR) and placement of cables contrary to the instructions for use may cause burns to the patient. #### Update of the field action: UPDATED ON 12/11/2017, the company presented the completion report of the field action, with sending of necessary evidences and corrective actions.
  • Reason
    According to the registry holder, failure to follow the instructions for use regarding the positioning of the coil sense body coil 1.5t and its cables relative to the patient and the entrance of the resonance may generate a risk situation such as the generation of resonances unplanned patient or high coil cable temperature.
  • Action
    The company will make an Alert to comply with the correct Instructions for Use. It emphasizes that the Instructions for Use provide safety warnings for hazardous situations regarding the positioning of the coil and its cables including (without limitation) a general warning to avoid burns and warnings about high SAR scanning. These types of events can be avoided by following the Instructions for Use, including: • Avoid circling or twisting cables (RF coil cables, ECG boxes and ECG electrodes) into the body coil (RF area ). Placing the cables in circles may cause excessive cable heating and may result in burns if you come into contact with the patient's skin. The cables should be directed parallel to the axis of the hole (channel where the patient is placed). / / • Avoid directing the RF coil cable assembly in the vicinity of the RF coil. Avoid direct contact of the patient's skin with the RF coil cable. All this can result in overheating of the place and, finally, in burns to the skin. The positioning of the RF coil cable assembly should therefore be done with care. Keep a distance of 2 cm from the patient's skin. Use the special spacer or pads of the standard accessory assembly where the cable assembly may touch the skin. / / • Never attempt to bend or force the coil in an abnormal shape. / / • Do not place the coil perpendicular to the magnetic field. /// • Always place the cable directly away from the region of interest./// • Position and grip (hold) the cable using the clips provided in the accessory gutter (Achieva 1.5T and 3.0T), or in the fittings of the mattress (3.0T TX systems). • Do not position any coil interface box on the patient's body. /// The interface box can be positioned in the patient in exceptional cases. Only. Use the special spacer or pads of the standard accessory set to create a distance to the patient's skin. (IFU [Instructions for Use] 2.18.11 Intera 1.5T, Achieva 1.5T; 2.18.8 ACS NT)

Device

Magnetic Resonance Imaging Equipment INTERA / ACHIEVA; risk class II, records: 10216710194; 10216...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V/ Philips Medical Systems Ltda.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA