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U.S. Department of Health and Human Services

Class 2 Device Recall RayStation

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  Class 2 Device Recall RayStation see related information
Date Initiated by Firm January 26, 2018
Create Date March 29, 2018
Recall Status1 Terminated 3 on January 13, 2020
Recall Number Z-1275-2018
Recall Event ID 79582
510(K)Number K171536  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19
UDI: 0735000201006820171130
Code Information Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Sveavaegen 9
Stockholm Sweden
Manufacturer Reason
for Recall		 Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.
FDA Determined
Cause 2		 Device Design
Action On January 26, 2018 RaySearch Laboratories AB sent Field Safety Notice, Medical Device Correction #25955 to each customer via e-mail. Customers were advised of the following: be aware that Center Beam in Field affects all beams that share the same isocenter and that apertures may be modified in a way not intended; do not use Center Beam in Field after having created an opposed beam. If an opposed beam has been created, delete the opposed beam and use Center Beam in Field on the remaining beam. Then recreate the opposed beam; please educate planning staff and all users about this workaround; inspect your product and identify all installed units with the above software version number(s), then confirm you have read and understood this notice by replying to the notification via email, fax or by calling local support. Customers with questions were instructed to contact David Hedfors via e-mail at david.hedfors@raysearchlabs.com
Quantity in Commerce 2484
Distribution Nationwide
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 = MUJ and Original Applicant = RaySearch Laboratories AB (publ)
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