| Date Initiated by Firm | July 22, 2025 |
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| Date Posted | September 02, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2486-2025 |
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| Recall Event ID |
97311 |
| Product Classification |
Fludeoxyglucose F18-guided radiation therapy system - Product Code QVA
|
| Product | RefleXion X1 Model RXM1000
UDI Codes:
(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
(01)00860003983812(11)240528(21)X11009
(01)00860003983812(11)240820(21)X11010
(01)00860003983812(11)241107(21)X11011
(01)00860003983812(11)241206(21)X11012
The RefleXion X1 is a radiation therapy system that combines the functionality of an emission computed tomography detection system and a linear accelerator. The device is intended for use with approved fludeoxyglucose F18. The emission computed tomography
detection system acquires images of positron-emitting fludeoxyglucose F18 for the purpose of guiding the delivery of megavoltage X-rays for oncologic treatment with radiation therapy using an FDA cleared, authorized, or approved linear accelerator. |
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| Code Information |
Model Number: RXM1000
UDI Codes that includes 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
(01)00860003983812(11)240528(21)X11009
(01)00860003983812(11)240820(21)X11010
(01)00860003983812(11)241107(21)X11011
(01)00860003983812(11)241206(21)X11012 |
| FEI Number |
3011716550
|
Recalling Firm/
Manufacturer |
Reflexion Medical, Inc.
25881 Industrial Blvd
Hayward CA 94545-2991
|
| For Additional Information Contact | Diana King
858-951-6926 |
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Manufacturer Reason
for Recall | Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead to adverse events (toxicity). |
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FDA Determined
Cause 2 | Software change control |
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| Action | On 07/22/2025, the firm sent an "Urgent Medical Device Recall Safety Notification (Correction)" Letter to customer informing them that RefleXion is initiating a Recall (Correction) of the RefleXion X1 System (model RXM1000). An issue has been identified with a configuration setting for the maximum number of fractions that can be delivered within a specified time period. The system should be configured to allow the delivery of up to two (2) fractions, including completion of partial fractions, for each treatment plan within a 12-hour period. As a result of this issue there is a potential to unintentionally administer more than two treatments in a 12-hour period, potentially leading to serious toxicity.
Customer are instructed to:
1) Acknowledge receipt of the email by signing and returning the attached Consignee Acknowledgment Form at their earliest convenience.
2) Until the configuration setting is corrected, RefleXion Medical advises users to employ current radiation therapy procedures within the clinic to perform daily checks of treatment session records for radiation therapy patients to prevent delivery of unintended fractions.
3) It is requested that customers post this notification on or near the RefleXion Medical RXM1000 system until this issue can be resolved.
For questions or assistance - email support@reflexion.com |
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| Quantity in Commerce | 11 |
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| Distribution | U.S. Nationwide distribution in the states of CA, CT, LA, NJ, OR, PA, and TX.
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| Total Product Life Cycle | TPLC Device Report |
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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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