Events

Recall of Device Recall RaySearch RayStation 4.7

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

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
    71414
  • Event Risk Class
    Class 2
  • Event Number
    Z-2457-2015
  • Event Initiated Date
    2015-05-27
  • Event Date Posted
    2015-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137704
  • 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,planning,radiation therapy treatment - Product Code MUJ
  • Reason
    Issue with the algorithm for roi contraction in raystation 4.7 when non-uniform contraction distances are used. the roi contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. these contraction distances are, in error, pairwise reversed, i.E. right is interpreted as left, inferior is interpreted as superior, and posterior is interpreted as anterior.
  • Action
    On May 27, 2015 RaySearch Laboratories distributed Medical Device Correction notices to their customers via courier service. Within the Medical Device Correction notice, RaySearch Laboratories included a workaround to the problem for their customers. Customers should not use structure templates containing derived ROI definitions with non-uniform contractions. They should avoid using non-uniform contractions. In the case non-uniform contractions must be used, enter switched distances manually and review the result carefully before using it for treatment planning. Lastly, do not use humerus shielding in Automatic Breast Planning. Customers are also expected to complete and return the lower portion of the correction notice via fax to 888-501-7195. **CAPA** Correct the software problem in patch version 4.7.2 of RayStation 4.7, scheduled for market release June 2015.

Device

Device Recall RaySearch RayStation 4.7
  • Model / Serial
    software build numbers are 4.7.1.10
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in CO, IL, MI, NC, OH,TN, and WA.
  • Product Description
    RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB