Events

Alerta De Seguridad para Commercial name: Prodigy Lunar Bone Densitometer. ANVISA registry number: 80071260163. Class of risk: III. Affected model (s); and Lot (s) / Serial number (s) affected :. The following software versions: 15, 15 SP1, and 15 SP2 are affected by the products. - Bone Densitometer (Model: DPX - NT and Record: 80071260176). - Bone Densitometry System (Model: Lunar iDXA and Record: 80071260178). - Prodigy Lunar Bone Densitometer (Model: Prodigy, Prodigy Advance, Prodigy Primo and Prodigy Pro - Record: 80071260163).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.; GE Healthcare do Brasil.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1774
  • Fecha
    2015-12-15
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    According to the company, the occurrence of specification failure may result in an unnecessary radiation emission to the patient. However, the amount of radiation used is extremely low - less than one-tenth of a standard chest x-ray, and less than one-day exposure to natural radiation (RSNA - North American Radiological Society and ACR - American College of Radiology, 2014). The normal settings and use of ionizing radiation from a low-dose x-ray system are considered to be very safe and are unlikely to produce a short- or long-term side effect. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client.
  • Causa
    Ge healthcare became aware of non-compliance in the prodigy, idxa and dpx-nt densitometry systems. the identified fault can occur after the use of the repositioning function. it is possible that the encore software calculates an incorrect scan length, which can result in an unnecessary radiation emission to the patient.
  • Acción
    Letter delivery with reinforcement of instructions for use to mitigate risk. Field Action Code: IMF 14011. To avoid the emission of unnecessary radiation to the patient: 1) The user should check the scan length displayed on the positioning screen. Then do the scan. For anterior-posterior (AP) spine exams, most patients require a scan length of less than 20 cm. If the scan length is higher, set the value to 20 cm. 2) Monitor the exam during execution and select Abort when the user determines that the sufficient anatomical measurement area has been obtained. In spinal examinations, sufficient anatomical area is obtained when approximately half of the T12 thoracic vertebra is visible. //// Step-by-step instructions for correcting the security problem can be found in the Urgent Notice Letter or through the instructions contained in the enCORE, Rev. 12 User Manual (see page 68 for Abortion Measurement [Abort Measurement] and page 83 for AP Spine Analysis]. Following these instructions correctly will prevent the emission of unnecessary radiation to the patient.

Device

Commercial name: Prodigy Lunar Bone Densitometer. ANVISA registry number: 80071260163. Class of r...

Manufacturer

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.; GE Healthcare do Brasil