Manufacturers

SuperDimension, Inc.

2 devices in the database

Device Recall superDimension Bronchus System
  • Model / Serial
    All codes of disposable system components (Locatable Guide and Extended Working Channel).
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Austria, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, South Africa, Spain, Switzerland, Turkey, and United Kingdom.
  • Product Description
    Disposable components of the superDimension Bronchus System: Locatable Guide Kit (AKI00017-01) and Extended Working Channel (AKI00041-01).
Device Recall superDimension Bronchus System
  • Model / Serial
    superDimension Bronchus System with the following serial numbers: S0030019, S030051, S030052, S030054, S030055, S030058 thru S030062, S030067, S030068, S030077 thru S030081; S030084, S030085, S030088 thru S030095; S030097 thru S030100, S030103, S030104, S030105, S030390, S030447, S030449, S0030009, S0030011, S0030013, S0030014, S0030015, S0030021, S0030022, S0030026, S0030042, S030043 thru S030050, S030053, S030056, S030057, S030063, S030064, S030066, S030069 thru S030076, S030082, S030086, S030087, S030096, S030102, S030477.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Austria, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, South Africa, Spain, Switzerland, Turkey, and United Kingdom.
  • Product Description
    superDimension Bronchus System (AAS00016-01), an image-guided localization system used to guide endoscopic tools to predetermined targets within the pulmonary tract.

One manufacturer with a similar name

Learn more about the data here

superDimension, Inc.
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • 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.
  • Source
    SATP