Z-1933-2024Class II

RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device...

Name: Z-1933-2024 RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device...
Creator: Reflexion Medical, Inc.
Published: 2024-04-16
License: https://open.fda.gov/license/

Reflexion Medical, Inc. / initiated 2024-04-16 / Open, Classified / root cause: software

FDA source

Reflexion Medical, Inc. began a recall of RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission... on 2024-04-16. FDA classified it as Class II and gives the reason as "A potential dose error exists for patients treated with an out of session SCINTIX partial fraction". 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-1933-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-16
Posted: 2024-05-30
Recalling firm: Reflexion Medical, Inc.
Product: RefleXion 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.
Product code: QVA Fludeoxyglucose F18-Guided Radiation Therapy System
Reason for recall: A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
Root cause tag: software
FDA root cause: Software design
Action: On 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 [email protected]
Quantity in commerce: 7 systems
Distribution: U.S.: CA, CT, NJ, OR, PA and TX No O.U.S.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1933-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1933-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-30

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)