| | Class 2 Device Recall |  |
| Date Initiated by Firm | February 09, 2026 |
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| Date Posted | March 27, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1656-2026 |
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| Recall Event ID |
98518 |
| Product Classification |
Fludeoxyglucose F18-guided radiation therapy system - Product Code QVA
|
| Product | RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 |
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| Code Information |
Software Version: 2.1.29-4 and Software Version: 2.1.35-1.
UDI: (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,
(01)00860003983812(11)250731(21)X11013. |
| FEI Number |
3011716550
|
Recalling Firm/
Manufacturer |
Reflexion Medical, Inc.
25881 Industrial Blvd
Hayward CA 94545-2991
|
| For Additional Information Contact | Phil Aulson
650-390-7525 |
|---|
Manufacturer Reason
for Recall | Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose. |
|---|
FDA Determined
Cause 2 | Software change control |
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| Action | On 2/9/2026, recall notices were emailed to customers who were informed of the following:
How to recognize that the device may fail:
Any patient treatment with a roll offset applied in a localization followed by a subsequent repeat localization within the same treatment session will be affected. For patient treatments that have already occurred, measuring the approximate distance off-axis (R) and the maximum roll offset value (., in radians) can provide an approximate displacement value (S) through a simple mathematical formula, which may be helpful in estimating the severity of the dose impact for the patient.
Customers were asked to do the following:
1) Notify your clinical staff of the recall, including posting this notification on or near the system until this issue can be resolved.
2) Halt utilization of the Repeat Localization feature for all treatment and imaging sessions.
a. Note: Standard Roll corrections may still be used on the system if they are only applied in the localization immediately prior to the treatment delivery or imaging session commencing, as those are unaffected by this issue.
3) If a Roll correction is applied in an initial Localization and a Repeat Localization is initiated, the user should end the treatment session without continuing to treatment delivery or PET imaging. The user should restart the treatment session as a new treatment session to properly apply the Roll correction in the initial Localization without performing a Repeat Localization afterwards.
4) Complete and return the acknowledgement form.
Questions or additional assistance can be sent to the firm at support@reflexion.com |
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| Quantity in Commerce | 12 |
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| Distribution | US: CA, TX, PA, CT, NJ, OR, LA, OH |
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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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