Signia Power Handle

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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.
  • Manufacturers representative
    Medtronic Saudi Arabia
  • Source
    SFDA

9 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model: , Affected: Item code SIGPHANDLE
  • Manufacturer
  • Model / Serial
    SIGPHANDLE-UDI 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  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (Nationwide).
  • Product Description
    Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) || The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.
  • Manufacturer
  • Model / Serial
  • Product Description
    Surgical equipment/ Anaesthesia - surgical equipment
  • Manufacturer
  • Model / Serial
  • Product Description
    Covidien Signia Power Handles, Covidien llc
  • Manufacturer
  • Model / Serial
  • Product Description
    Covidien (Medtronic): Signia Power Handle
  • Manufacturer
4 more