Events

Recall of Device Recall Stereotactic Circular Collimator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Elekta, 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
    60150
  • Event Risk Class
    Class 2
  • Event Number
    Z-0319-2012
  • Event Initiated Date
    2011-03-25
  • Event Date Posted
    2011-11-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104613
  • 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
    Neurological stereotaxic instrument - Product Code HAW
  • Reason
    Recent newspaper articles outlined improper use of srs cone collimator accessories that injured patients on brainlab and varian systems.
  • Action
    Elekta sent an IMPORTANT NOTICE letter dated March 25, 2011 to all affected customers. The letter identified the affected product, the problem, key safety procedures and information to users for safe operation of the Stereotactic Circular Collimator. Elekta will issue a Mandatory Action Field Change Order which will include an updated Circular Collimator Instructions for Use - 102022201 and new labels. The notice instructs Users to file this document in the Important Notice section of the appropriate User Manual. Also, Elekta is offering some free WebEx sessions which will include the procedures and recommended operation of these types of accessories. Customers are instructed to register at www.elekta.com/SafeAccessories.

Device

Device Recall Stereotactic Circular Collimator
  • Model / Serial
    848, 849, 850, 851, 852, 853, 1032, 1033, 1034, 928, 929, 930, 931, 932, 801, 802, 803, 804, 805, 980, 981, 982, 983, 984, 889, 890, 891, 892, 893, 894, 908, 909, 910, 911, 912, 833, 834, 835, 836, 837, 843, 844, 845, 846, 847, 1017, 1018, 1019, 1020, 1021, 903, 904, 905, 906, 907, 883, 884, 885, 886, 933, 935, 936, 937, 940, 974, 975, 976, 977, 978, 941, 942, 943, 944, 945, 946, 947, 948, 949, 950, 1012, 1013, 1014, 1015, 1016, 1027, 1028, 1029, 1030, 1031
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) - including the states of: AZ, CA, FL, GA, MO, NJ, NM, NC, OR, TN, and WV
  • Product Description
    Stereotactic Circular Collimator || Product Usage: This device is intended to hold a patient's head in a fixed position and to localize and center the output of a linear accelerator (UNAC) to allow radiotherapy of brain tumors and other types of cerebral lesions.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Manufacturer Address
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA