Events

Recall of Device Recall superDimension Systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by superDimension, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62381
  • Event Risk Class
    Class 2
  • Event Number
    Z-2001-2012
  • Event Initiated Date
    2012-06-18
  • Event Date Posted
    2012-07-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110377
  • Notes / Alerts
    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.
  • Extra notes in the data
    Orotrachael intubation guide kit - Product Code OGK
  • Reason
    Superdimension, inc., is conducting a recall of certain superdimension systems operating software version 4.0 - 4.9. the affected systems are sold under the product code aas00016-xx. the products being recalled have been found to malfunction when connected to the superdimension locatable guide (lg). specifically, the systems using software version 4.0-4.9 will not recognize the locatable guide.
  • Action
    superDimension sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 15, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter advised customers to discontinue use of the system and requested consignees to complete and return the acknowledgement receipt form via fax to 763-210-4098. Contact the firm at 763-210-4057 for questions regarding this recall.

Device

Device Recall superDimension Systems
  • Model / Serial
    S030097 S0030044 S030065 S030092 S030579 S420011 S420102 I4202008 S0030045 S030066 S030092 S030586 S420012 S420105 I4202012 S00312 S030067 S030094 S030587 S420013 S420107 S0030011 S030043 S030069 S030096 S030588 S420015 S420108 S0030013 S030046 S030070 S030098 S030604 S420019 S420109 S0030014 S030049 S030072 S030099 S030605 S420020 S420110 S0030015 S030052 S030075 S030102 S030608 S420021 S420112 S0030017 S030054 S030076 S030105 S030609 S420026 S420114 S0030021 S030056 S030077 S030449 S300049 S420036 S420125 S0030022 S030057 S030080 S030477 S300082 S420037 S830001 S0030023 S030058 S030081 S030492 S310078 S420077  S0030024 S030059 S030083 S030541 S310100 S420079  S0030025 S030060 S030085 S030546 S420006 S420080  S0030026 S030061 S030087 S030547 S420008 S420092  S0030042 S030064 S030089 S030573 S420009 S420100
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, and Wisconsin and the countries of Canada, Australia, Austria, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, South Africa, Spain, Switzerland, Turkey, and United Kingdom.
  • Product Description
    superDimension Systems AAS00016-xx with Software Version 4.0-4.9. || Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
  • Manufacturer
    superDimension, Inc

Manufacturer

superDimension, Inc
  • Manufacturer Address
    superDimension, Inc, 161 Cheshire Ln N Ste 100, Minneapolis MN 55441-5433
  • 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
    USFDA