Events

Recall of Device Recall Proteus Plus and Proteus ONE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ion Beam Applications S.A..

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
    77175
  • Event Risk Class
    Class 2
  • Event Number
    Z-2592-2017
  • Event Initiated Date
    2017-02-09
  • Event Date Posted
    2017-06-19
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155167
  • 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
    System, radiation therapy, charged-particle, medical - Product Code LHN
  • Reason
    It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in pencil beam scanning (pbs) treatment mode when system is not irradiating between layers.
  • Action
    Ion Beam Application S.A. (IBA) will bring the defect into compliance: 1. Providing recommendations for user actions which, if followed, will prevent dark current. In order to prevent the error from occurring, the IBA customers are provided with a specific QA map that would detect dark current and instructions on how and when to use it (Annex 1). This guidance was included in IBAs User Notice which was sent to users on February 9, 2017. 2. IBA is developing a long term solution consisting of a new IC-cyclo (ionization chamber located at the cyclotron exit) and a Beam Absence Electronic Unit (BAEU) along with a software upgrade. This solution will detect presence of dark current between irradiations. It will prevent starting a new irradiation if dark current is present. This solution is currently in test phase and will be completed in two years. 3. Manufacturer will provide the FDA with progress reports on the effectiveness of the plan, including the number of electronic products repaired on a quarterly basis. The first progress report will be provided to the FDA by September 15, 2017 to the correspondence identified below. CDRH approves the CAP subject to the following conditions: 1.Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2.Any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge. For further questions please call (571) 449-4992.

Device

Device Recall Proteus Plus and Proteus ONE
  • Model / Serial
    Serial Numbers: PAT.000,PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.111, PAT.112, PAT.113, PAT.114, SAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : MA, FL, VA, PA, IL, NJ, WA, TN, LA and TX., and to the countries of: Germany, South Korea, France, Czech Republic, Italy, Poland and Sweden.
  • Product Description
    Proteus 235
  • Manufacturer
    Ion Beam Applications S.A.

Manufacturer

Ion Beam Applications S.A.
  • Manufacturer Address
    Ion Beam Applications S.A., Chemin du Cyclotron, 3, Louvain La Neuve Belgium
  • Manufacturer Parent Company (2017)
    Ion Beam Applications SA
  • Source
    USFDA