Events

Recall of Device Recall Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2

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
    57688
  • Event Risk Class
    Class 2
  • Event Number
    Z-1555-2011
  • Event Initiated Date
    2007-08-23
  • Event Date Posted
    2011-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97006
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Reason
    Under certain conditions it has been found that movement of the collimators can be induced during multi segment beams such as imrt and omniwedge which will not be detected by the desktop pro if high values are sent within the icom tolerance table.
  • Action
    The firm, Elekta, sent an "Important Notice A302" dated August 23, 2007 titled "Update to iCom Tables for Desktop Pro when used with Third Party R&V; Systems",to all affected customers. On September 28, 2007, Elekta issued a second Important Notice A304 which reiterated the same information as was in Important Notice A302. The notices described the product, problem and actions to be taken. This notice provides a workaround on how to avoid the issue. In order to avoid this issues documented, Elekta recommended that the customers set the tolerance for collimators in the iCom tolerance table to be 3.0 degrees-no less than 3.0 and to use the Linac Record, if configured, as a means of checking the final collimator position. Elekta noted that the issue will be resolved in a future release of Desktop Pro. If you any questions related to this issue, please contact your local Elekta, third party R&V; system representative or Elekta Limited at +44 (0)1293 654200.

Device

Device Recall Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2
  • Model / Serial
    134615, 134621, 134091, 136364, 134172, 136285, 134605, 134183, 136167, 136234, 134259, 134115, 134081, 136047, 136063, 134701, 134328, 134391, 134432, 134436, 134438, 136119, 134535, 134561, 134475, 134564, 134154, 134269, 134348, 134399, 136084, 136087, 136100, 134200, 134118, 134822, 134018, 136368, 134241, 134606, 134711, 134473, 134787, 134768, 134571, 134237, 134104, 136009, 134331, 134272, 136322, 136175, 136200, 134503, 136257, 134322, 134781, 134380, 134709, 136108, 134250, 134254, 134258, 134206, 134195, 134094, 134652, 134704, 136107, 134469, 134472, 134483, 134519, 134729, 136109, 134236, 134239, 134197, 134456, 134047, 134092, 134211, 136373, 134275, 134679, 136106, 136163, 134667, 136181, 134169, 134329, 134126, 134090, 134358, 134427, 134626, 134819, 134027, 134265, 134597, 136319, 134220, 134256, 134396, 134804, 134235, 136338, 134137, 134234, 134249, 136034, 136065, 136110, 136267, 136291, 134213, 134219, 136330, 134750, 136097, 136270, 134457, 134078, 134129, 136195, 134375, 134603, 136074, 134075, 134565, 134196, 134428, 134430, 134008, 134382, 134070, 134157, 134772, 136080, 134860, 134401, 134368, 134388, 134631, 134318, 136015, 136096, 134563, 136165, 136240, 134441, 134017, 134048, 134189, 134395, 134324, 134595, 134140, 134212, 136086, 134354, 136178, 136317, 136318, 134445, 136012, 136332, 134321, 136071, 136089, 136292, 136293, 134673, 134685, 136059, 136169, 134073, 134748, 134754, 134378, 134383, 134458, 134192, 134499, 136069, 136092, 134642, 134295, 134671, 136046, 136147, 134062, 136049, 136036, 136152, 136157, 136083, 136081, 134770, 136118, 136156, 136172, 134352, 134548, 134533, 136153, 136269, 136197, 136252, 136286, 136315, 136241, 134811, 134812, 136258, 136312, 134069, 136310, 134864, 134040, 134046, 134307
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including Puerto Rico and countries including: Canada and Mexico.
  • Product Description
    Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2 || A user interface of rthe SL/SLi Series Linear Accelerators that are used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • 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