Retiro De Equipo (Recall) de Device Recall Bravo pH Monitoring capsule

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Given Imaging Ltd..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Monitor, fetal ph - Product Code LLT
  • Causa
    Failure of the bravo capsule to attach to the esophagus or alternatively, failure of the capsule to detach from the placement device.
  • Acción
    Given Imaging sent a Urgent Product Recall letter to all affected consignees. The letter identified the product, description of problem, actions to be taken and advised customers to read this important information packet in its entirety. Customers were advised to complete the Customer Response Sheet included and return per the instructions provided. Also attached to the letter was a Customer Bulletin: Update to Vacuum Settings. For questions call 1-800-448-3644 option 3.


  • Modelo / Serial
    FGS-0312 (5 pack), Lot numbers: 11775Q, 12064Q, 12227Q, 12333Q, 12389Q, 12440Q, 12475Q, 12494Q, 12643Q, 12545Q, 12769Q, 12770Q, 12840Q, 12896Q, 12897Q, 12928Q, 12989Q, 13026Q, 13056Q, 13109Q, 13109Q, 13162Q, 13164Q, 13208Q, 13233Q, 13246Q, 13282Q, 13283Q, 13371Q, 13390Q, 13462Q, 13461Q, 13540Q, 13569Q, 13634Q, 13679Q, 13695Q, 13700Q, 13712Q, 13716Q, 13753Q, 13777Q, 13786Q, 13798Q, 13799Q, 13813Q, 13836Q, 13867Q, 13894Q, 13937Q, 13979Q, 14064Q, 14101Q, 14120Q, 14141Q, 14230Q, 14255Q, 14265Q, 14284Q, 14338Q, 14400Q, 14419Q, 14423Q, 14458Q, 14491Q, 14542Q, 1457QQ, 14572Q, 14570Q, 14611Q, 14634Q, 14734Q, 14770Q, 14805Q, 14825Q, 14826Q, 14871Q, 15030Q, 15051Q, 15071Q, 15078Q, 15114Q, 15158Q, 15221Q, 15324Q, 15406Q, 15401Q, 15500Q, 15603Q, 15630Q, 15672Q, 15679Q, 15711Q, 15787Q, 15860Q, 15912Q, 15938Q, 15971Q, 15998Q, 16115Q, 16144Q, 16192Q, 16221Q, 16320Q, 16290Q, 16354Q, 16382Q, 16395Q, 16449Q, 16503Q, 16511Q, 16580Q, 16606Q, 16607Q, 16673Q, 16762Q, 16867Q, 16762Q & 16847Q and FGS-0313 (single pack), Lot numbers: 12647Q, 12765Q, 12797Q, 12902Q, 13234Q, 13458Q, 13608Q, 13632Q, 13635Q, 13751Q, 13868Q, 13907Q, 14011Q, 14065Q, 14231Q, 14339Q, 14402Q, 14612Q, 14761Q, 14783Q, 14865Q, 14984Q, 15222Q, 15538Q, 15698Q, 15766Q, 15937Q, 16392Q, 16194Q, 16398Q, 16707Q, 16879Q, 17058Q & 16912Q. Recall expanded on 02/20/2012 to include additional lot numbers: 17102Q, 17188Q and 17227Q.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Austria, Belgium, Brazil, Denmark, Canada, Cyprus, Finland, Germany, Hong Kong, India, Indonesia, Israel, Italy, Japan, Mexico, Netherlands, Norway, New Zealand, Panama, Portugal, Singapore, Sri Lanka, South Africa, Spain Thailand, Turkey, United Kingdom and Venezuela.
  • Descripción del producto
    Bravo pH Monitoring capsule, UPC 7290101361695 (FGS# 0312) and UPC 7290101361688 (FGS# 0313). || Product Usage: || The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children form 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry.
  • Manufacturer


  • Dirección del fabricante
    Given Imaging Ltd., 5555 Oakbrook Pkwy, Norcross GA 30093-6254
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source