Z-1656-2026Class II

RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00

Name: Z-1656-2026 RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Creator: Reflexion Medical, Inc.
Published: 2026-02-09
License: https://open.fda.gov/license/

Reflexion Medical, Inc. / initiated 2026-02-09 / Open, Classified / root cause: software

FDA source

Reflexion Medical, Inc. began a recall of RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 on 2026-02-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1656-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-09
Posted: 2026-03-27
Recalling firm: Reflexion Medical, Inc.
Product: RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Product code: QVA Fludeoxyglucose F18-Guided Radiation Therapy System
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.
Root cause tag: software
FDA root cause: Software change control
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 [email protected]
Quantity in commerce: 12
Distribution: US: CA, TX, PA, CT, NJ, OR, LA, OH
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1656-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1656-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27

Product code QVA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)