Devices

Device Recall Bravo pH Monitoring capsule

  • 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
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • 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
    Given Imaging Ltd.
  • 1 Event

Fabricante

Given Imaging Ltd.
  • Dirección del fabricante
    Given Imaging Ltd., 5555 Oakbrook Pkwy, Norcross GA 30093-6254
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • 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
    USFDA