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U.S. Department of Health and Human Services

Class 2 Device Recall RefleXion X1

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 Class 2 Device Recall RefleXion X1see related information
Date Initiated by FirmApril 16, 2024
Date PostedMay 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1933-2024
Recall Event ID 94533
Product Classification Fludeoxyglucose F18-guided radiation therapy system - Product Code QVA
ProductRefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator.
Code Information Model Number: RXM1000 UDI Codes that includes system serial numbers: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007 (01)00860003983812(11)230803(21)X11008
FEI Number 3011716550
Recalling Firm/
Manufacturer		 Reflexion Medical, Inc.
25881 Industrial Blvd
Hayward CA 94545-2991
For Additional Information ContactDiana King
650-248-5714
Manufacturer Reason
for Recall		A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
FDA Determined
Cause 2		Software design
ActionOn 04/29/2024, the firm sent an "Urgent: Medical Device Recall Safety Notification" via email to customer informing them that during internal dosimetric testing of SCINTIX OOS partials in periodic tracking mode, it was observed that the delivered dose error of the full fraction can exceed 5% with respect to the upper bound of one or more static volumes within the DVH in the plan (non-tracked, non-target volumes in the patient frame of reference, i.e., the planning CT). This was determined to be the result of a software defect associated with completing interrupted. Customers are instructed to: 1. Notify all clinical staff of this recall 2. Utilized the Clinical Guidance Document that is include with this notification. For questions or concerns - contact Service and Support at 650-239-9070 or email support@reflexion.com
Quantity in Commerce7 systems
DistributionU.S.: CA, CT, NJ, OR, PA and TX No O.U.S.
Total Product Life CycleTPLC 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.
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