Z-0470-2022Class II

RefleXion Medical Radiotherapy System - System Label: "* refleXion REF RXM1000 *" Physics Guide/Treatment...

Name: Z-0470-2022 RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment...
Creator: Reflexion Medical, Inc.
Published: 2021-11-24
License: https://open.fda.gov/license/

Reflexion Medical, Inc. / initiated 2021-11-24 / Terminated / root cause: software

FDA source

Reflexion Medical, Inc. began a recall of RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User... on 2021-11-24. FDA classified it as Class II and gives the reason as "Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0470-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-24
Posted: 2022-01-10
Terminated: 2024-07-08
Recalling firm: Reflexion Medical, Inc.
Product: RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS).
Root cause tag: software
FDA root cause: Software design
Action: On 11/24/2021 and 12/02/2021, the firm emailed customers to inform them of an ongoing investigation a potential dose discrepancy while treating patients in an orientation other than Head First Supine (HFS), i.e., Feet First Supine (FFS) and Head First Prone (HFP) and Feet First Prone (FFP). On 12/22/2021, the firm sent an "Urgent Safety Notification" letter to customers informing them that the Recalling Firm has confirmed that a dose discrepancy exists for patients treated in any orientation other than Head First Supine (HFS). Customers are instructed, until the updated software is install at their institution, the Recalling Firm recommends using only the HFS orientation when treating patients on the affected systems. It is estimated that a software updated to address the issue will be installed at all sites by mid to late January 2022. For questions, contact the Senior Director of Technical Support at 650-263-8888 or email [email protected]
Quantity in commerce: 3 devices
Distribution: U.S. Nationwide distribution in the states of CA and TX
Product codes and lots: Model: RXM1000 Serial Numbers/UDI Codes: X11001 / (01)00860003983805(11)210125(21)X11001 X11002 / (01)00860003983805(11)210324(21)X11002 X11003 / (01)00860003983805(11)210524(21)X11003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0470-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0470-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-19	2022-01-10

Product code IYE

K190978Class IIRefleXion Medical Radiotherapy SystemReflexion Medical, Inc. / cleared 2020-03-12

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)