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U.S. Department of Health and Human Services

Class 2 Device Recall RayStation

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 Class 2 Recall
RayStation
see related information
Date Posted December 02, 2011
Recall Status1 Terminated on May 11, 2012
Recall Number Z-0359-2012
Recall Event ID 60409
Premarket Notification
510(K) Number
K100552 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product RayStation Version 2.0.0.15 Consult instruction for use. RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. support@raysearchlabs.com RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
Code Information Software version and build number is 2.0.0.15
Recalling Firm/
Manufacturer
RAYSEARCH LABORATORIES AB
Sveavaegen 9
Stockholm
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The firm has found an issue with DICOM RT Image representation of DRR images from RayStation 2.0 which needs to be clarified in the user manual. The symptoms involve the Pixel Spacing and Image Position attributes in the RT images being incorrect, thus enabling the user to make measurements that are erroneous and possibly misalign the patient.
FDA Determined
Cause 2
DESIGN: Device Design
Action The firm, RaySearch Laboratories, sent an email with an "Urgent Field Safety Notice Medical Device Correction" notice dated October 19, 2011 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to pass on the information in the field safety notice to everyone involved and create routines to compensate for the incorrect DRR images; if the DICOM DRR images are not used to make any form of absolute measurements, no action needs to be taken. Raysearch laboratories will provide a script to update these DICOM files to have the correct values upon request. For further information please contact RaySearch Laboratories AB Quality and Regulatory Affairs Manager at +46 722 366 110 or david.hedfors@raysearchlabs.com; RaySearch Americas Director of Customer Support at +1 877 778 3489 or freddie.cardell@raysearchlabs.com.
Quantity in Commerce 19 units
Distribution Worldwide distribution: USA (nationwide) including states of: MA, NJ, and NY; and country of: Netherlands
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = RAYSEARCH LABORATORIES AB
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