Events

Alerta De Seguridad para Amplimat 5-Field Chamber

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Philips Medical Systems.

¿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
  • Fecha
    2012-10-19
  • Fecha de publicación del evento
    2012-10-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121019.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: philips amplimat 5-field chamber medical device manufacturer, philips medical systems, has issued a medical device safety alert concerning all units of digitaldiagnost, essenta dr, essenta dr compact, buckydiagnost, easydiagnost eleva and traumadiagnost using the 5-field amplimat chamber, serial numbers from 11320067 to 11321695 and from 11322000 to 11322231. if direct radiation hits an amplimat field (selected or unselected), the amplimat signal amplifier can enter an undefined state, and one or more of the following automated exposure control (aec) exposures (using the amplimat) can be overexposed. as a result, the generator does not switch off the exposure when the intended dose is reached; however, it does switch off when the backup shutoff condition is reached. if the pre-programmed apr/epx settings are used, the overexposure is small and the image generated is usable for diagnostic purposes. if the operator overrides the pre-programmed settings, the image generated may be unusable (i.E. not correctly exposed) and more radiation may be administered than intended. the manufacturer advised the affected users to take the following actions: use the pre-programmed apr/epx settings for aec technique exposures. if overriding the apr/epx settings, monitor the exposure time. if the exposure time is longer than expected, abort the exposure. the decision if a retake is required or not should be based on the expected benefit in relation to the radiation risk. the manufacturer will instruct field service engineer to remove the affected amplimat chamber for devices with serial numbers from 11320067 to 11321695 and from 11322000 to 11322231, and install a new one. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 19 october 2012.

Device

Amplimat 5-Field Chamber
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips Amplimat 5-Field Chamber
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH