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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 February 23, 2024
Date Posted April 05, 2024
Recall Status1 Open3, Classified
Recall Number Z-1482-2024
Recall Event ID 94153
510(K)Number K190387  K200569  K210645  K211867  K220141  K222312  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
Code Information Version Number (Build Number/UDI): 8B (8.1.0.47/07350002010129), 8B SP1 (8.1.1.8/07350002010204), 8B SP2 (8.1.2.5/07350002010235), 9A (9.0.0.113/07350002010174), 9A SP1 (9.0.1.142/07350002010488), 9B (9.1.0.933/07350002010266), 9B SP1 (9.2.0.483/07350002010297), 10A (10.0.0.1154/07350002010303), 10A SP1 (10.0.1.52/07350002010365), 10A SP2 (10.0.2.10/07350002010655), 10B (10.1.0.613/07350002010310), 10B SP1 (10.1.1.54/07350002010471), 11A (11.0.0.951/07350002010389), 11A SP1 (11.0.1.29/07350002010433), 11A SP2 (11.0.3.116/07350002010440), 11A SP3 (11.0.4.15/07350002010631), 11B (12.0.0.932/07350002010426), 11B SP1 (12.1.0.1221/07350002010495), 11B SPC1 (12.1.1.41/07350002010587), 11B SP2 (12.0.3.68/07350002010501), 11B SPC2 (12.1.2.91/07350002010617), 11B SP3 (12.0.4.12/07350002010600), 11B SPC3 (12.1.3.162/07350002010662), 11B SPC4 (12.1.4.113/07350002010709), 11B SPC5 (12.1.5.60/07350002010747), 11B SPT1 (12.3.0.119/07350002010570), 12A (13.0.0.1547/07350002010549), 12A SP1 (13.1.0.144/07350002010679), 12A SP2 (13.1.1.89/07350002010730), 2023B (14.0.0.3338/07350002010556), 2024A (15.0.0.430/07350002010723).
Recalling Firm/
Manufacturer		 RAYSEARCH LABORATORIES AB
Eugeniavagen 18c
Stockholm Sweden
For Additional Information Contact Olympiada Lachana
46-8-51053000
Manufacturer Reason
for Recall		 A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.
FDA Determined
Cause 2		 Under Investigation by firm
Action On February 26, 2024, the firm notified customers of the issue via Urgent Field Safety Notice: Medical Device Correction letters via email. Actions to be taken by the user: 1. Educate planning staff and all users about the possibility of the described use error. 2. If the use error is deemed likely to occur at your clinic, take actions to ensure that proper review of assigned materials is performed before a patient model is used for treatment planning. 3. If you wish to have the Silicon chemical element removed from the material list, contact RaySearch support for assistance. This is especially recommended for clinics that perform ion beam treatments, where the harm caused by the use error could be significant. 4. Inspect your product and identify all installed units with the above software version number(s). 5. Confirm you have read and understood this notice by replying to the notification email. The Silicon chemical element will not be included in the next version of RayStation/RayPlan, scheduled for market release in April 2024 (subject to market clearance in some markets). If requested by the customer, it can be removed from the material list of existing installations. This notice needs to be passed on to all those who need to be aware within your organization. Maintain awareness of this notice as long as any affected version is in use. Thank you for your cooperation, and we apologize for any inconvenience. For regulatory information, please contact quality@raysearchlabs.com.
Quantity in Commerce 154 units
Distribution Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hong Kong S.A.R., Hungary, India, Indonesia, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, P.R. China, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = RaySearch Laboratories AB (publ)
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