Events

Recall of Device Recall Optical Surface Monitoring System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems, 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
    74585
  • Event Risk Class
    Class 2
  • Event Number
    Z-2149-2016
  • Event Initiated Date
    2016-06-23
  • Event Date Posted
    2016-07-11
  • 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=147984
  • 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
    Varian medical systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. this can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with optical surface monitoring system [osms].
  • Action
    The firm, Visionrt, sent an "URGENT MEDICAL DEVICE CORRECTION NOTIFICATION-URGENT FIELD SAFETY NOTIFICATION" letter dated June 24, 2016 to all affected customers. Letters describe the product, problem and actions to be taken. The customers were instructed as follows: DO NOT USE the "Move Couch" function if the couch rotation value set in the AlignRT device DOES NOT match the planned couch rotation for the treatment field; retain a copy of this document along with your most current product labeling; pass the letter to all those who need to be aware of it within their organization; always confirm that the patient is correctly aligned prior to commencing treatment; is not required to return their devices; promptly inform Vision RT if they believe that patient harm occurred, and complete Appendix 1- Customer Acknowledgment Response and return it via email to corrections@visionrt.com. Should you have any queries on this letter, please do not hesitate to contact Vision RT by telephone on +44 20 83464300 (866-778-2379 from the US) or as per http://www.visionrt.com/contact/details.

Device

Device Recall Optical Surface Monitoring System
  • Model / Serial
    TrueBeam version 2.0/2.5 with any version OSMS.  OSMA serial numbers: HOM0084 HOM0176 HOM0368 HOM0003 HOM0004 HOM0005 HOM0006 HOM0008 HOM0009 HOM0010 HOM0011 HOM0012 HOM0015 HOM0016 HOM0017 HOM0018 HOM0019 HOM0020 HOM0021 HOM0022 HOM0023 HOM0024 HOM0025 HOM0026 HOM0027 HOM0028 HOM0029 HOM0030 HOM0031 HOM0032 HOM0033 HOM0034 HOM0035 HOM0036 HOM0037 HOM0071 HOM0072 HOM0073 HOM0074 HOM0075 HOM0076 HOM0077 HOM0078 HOM0079 HOM0080 HOM0081 HOM0082 HOM0083 HOM0084 HOM0085 HOM0086 HOM0087 HOM0088 HOM0089 HOM0090 HOM0091 HOM0095 HOM0096 HOM0097 HOM0098 HOM0099 HOM0100 HOM0101 HOM0102 HOM0103 HOM0107 HOM0108 HOM0109 HOM0110 HOM0111 HOM0113 HOM0114 HOM0115 HOM0116 HOM0117 HOM0118 HOM0125 HOM0126 HOM0127 HOM0128 HOM0129 HOM0170 HOM0171 HOM0172 HOM0173 HOM0174 HOM0175 HOM0176 HOM0177 HOM0178 HOM0179 HOM0180 HOM0181 HOM0182 HOM0183 HOM0184 HOM0185 HOM0186 HOM0187 HOM0188 HOM0189 HOM0190 HOM0191 HOM0304 HOM0305 HOM0306 HOM0307 HOM0308 HOM0309 HOM0310 HOM0311 HOM0312 HOM0313 HOM0314 HOM0315 HOM0316 HOM0317 HOM0318 HOM0319 HOM0320 HOM0321 HOM0322 HOM0323 HOM0324 HOM0329 HOM0330 HOM0331 HOM0332 HOM0333 HOM0334 HOM0335 HOM0336 HOM0337 HOM0338 HOM0339 HOM0340 HOM0341 HOM0342 HOM0347 HOM0348 HOM0349 HOM0350 HOM0351 HOM0352 HOM0353 HOM0354 HOM0356 HOM0357 HOM0358 HOM0359 HOM0360 HOM0361 HOM0362 HOM0363 HOM0364 HOM0365 HOM0366 HOM0367 HOM0368 HOM0369 HOM0370 HOM0371 HOM0372 HOM0373 HOM0374 HOM0381 HOM0382 HOM0383 HOM0386 HOM0387 HOM0388 HOM0389 HOM0390 HOM0391 HOM0392 HOM0393 HOM0394 HOM0395 HOM0396 HOM0403 HOM0404 HOM0405 HOM0406 HOM0409 HOM0410 HOM0411 HOM0412 HOM0413 HOM0414 HOM0415 HOM0416 HOM0420 HOM0421 HOM0422 HOM0424 HOM0440 HOM0441 HOM0442 HOM0444 HOM0445 HOM0447 HOM0448 HOM0454 HOM0457 HOMWMZ1.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Austria, Azerbaijan, Brunei Darussalam, Bulgaria, Denmark, Georgia, Germany, India, Italy, Malaysia, Morocco, Norway, Portugal, Switzerland, and United Kingdom.
  • Product Description
    Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; || Radiology: The AlignRT Plus system is indicated for use to position || and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.
  • Manufacturer
    Varian Medical Systems, Inc.

Manufacturer

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