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U.S. Department of Health and Human Services

Class 2 Device Recall Optical Surface Monitoring System

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  Class 2 Device Recall Optical Surface Monitoring System see related information
Date Initiated by Firm June 23, 2016
Date Posted July 11, 2016
Recall Status1 Terminated 3 on August 24, 2018
Recall Number Z-2149-2016
Recall Event ID 74585
510(K)Number K123371  
Product Classification Accelerator, linear, medical - Product Code IYE
Product 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.
Code Information 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.  
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc.
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact K. Jeffrey Semone
650-424-6833
Manufacturer Reason
for Recall		 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].
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 166 OSMS in US, 23 OSMO - International,
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = VISION RT LIMITED
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