Events

Recall of Device Recall FramelessArray software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems Oncology Systems.

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
    37811
  • Event Risk Class
    Class 2
  • Event Number
    Z-0905-2007
  • Event Initiated Date
    2007-03-14
  • Event Date Posted
    2007-06-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-07-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51590
  • 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, software - Product Code IYE
  • Reason
    Localization error; with planning data transferred to the optical guidance platform via dicom rt; the software incorrectly computes the center of the ct volume, resulting in a potential axial error ranging from 0.3 mm to 1.5 mm, affecting both fractionated and stereotactic radiosurgery (srs) treatments.
  • Action
    The recalling firm notified consignees by certified letter on 03/14/07. The notification was flagged as "Urgent Medical Device Correction" and advised end users that a localization error may occur when using the FramelessArray and affect its accuracy for Frameless treatments. Users were instructed to verify software in the devices and if running FramelessArray version 1.0, to discontinue use of the software when Stereotactic Radiosurgery plans are transfered via DICOM RT. The notification offered that firmware would be upgraded during scheduled service visit.

Device

Device Recall FramelessArray software
  • Model / Serial
    S/Ns: HZ60006 HZ60008 HZ60012 HZ60035 HZ60049 HZ60053 HZ60054 HZ60057 HZ60061 HZ60062 HZ60064 HZ60072 HZ60079 HZ60095 HZ60096 HZ60106 HZ60109 HZ60112 HZ60119 HZ60144 HZ60161 HZ60162 HZ60168 HZ60185 HZ60186 HZ60218 HZ60222 HZ60225 HZ60232 HZ60233 HZ60234 HZ60266 HZ60267 HZ60268 HZ60269 HZ60270 HZ60293 HZ60294 HZ60308 HZ60350 HZ60389 HZ60390 HZ60398 HZ60399 HZ60403 HZ60404 HZ60406 HZ60414 HZ60415 HZ60416 HZ60426 HZ60460 HZ60463 HZ60464 HZ60471 HZ60478 HZ60507 HZ60508 HZ60509 HZ60513 HZ60532 HZ60533 HZ60537 HZ60540 HZ60549 HZ60557 HZ60561 HZ60564 HZ60569 HZ60577 HZ60595 HZ60612 HZ60617 HZ60620 HZ60625 HZ60626 HZ60639 HZ60640 HZ60646 HZ60649 HZ60654 HZ60656 HZ60662 HZ60667 HZ60670 HZ60674 HZ60675 HZ60681 HZ60683 HZ60684 HZ60686 HZ60698 HZ60703 HZ60713 HZ60726 HZ60731 HZ60740 HZ64006 HZ65070 HZ66006 HZ66026 HZ66041 HZ66070 HZ66077 HZ66118 HZ66175 HZ66299 HZ67029 HZ67035 HZ67066 HZ67068 HZ67079 HZ67085 HZ67118 HZ67126 HZ67131 HZ67142 HZ68004 HZ68010 HZ68017 HZ68018 HZ68026 HZ68035 HZ68043 HZ68051 HZ68055 HZ68060 HZ68066 HZ68068 HZ68069 HZ68078 HZ68079 HZ68087 HZ68095 HZ68099 HZ68118 HZ68128 HZ68134 HZ68197 HZ68264 HZ68998 HZ69001 HZ69003 HZ69004 HZ69007 HZ69013 HZ69028 HZ69036 HZ69043 HZ69045 HZ69046 HZ69068 HZ69072 HZ69077 HZ69085 HZ69088 HZ69096 HZ69098 HZ69109 HZ69118 HZ69120 HZ69121 HZ69126 HZ69131 HZ69134 HZ69155 HZ69158 HZ69170 HZ69171 HZ69172 HZ69175 HZ69186 HZ69190 HZ69201 HZ69223 HZ69330 HZ60495 HZ60586
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide : The software was distributed to direct accounts in the US and internationally distributed to accounts in Canada, Australia and Spain.
  • Product Description
    FramelessArray software, Version 1.0. ; Medical Device firmware incorporated with the RadioCamera Extracranial System, distributed by Varian Medical System, Palo Alto, CA.
  • Manufacturer
    Varian Medical Systems Oncology Systems

Manufacturer

Varian Medical Systems Oncology Systems
  • Manufacturer Address
    Varian Medical Systems Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Manufacturer Parent Company (2017)
    Varian Medical Systems Inc
  • Source
    USFDA