RefleXion Medical Radiotherapy System recallZ-0470-2022 · Reflexion Medical, Inc. · initiated Nov 24, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Reflexion Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Software design
What the company is doing
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]
Recall details
- Recall number
- Z-0470-2022
- Status
- Terminated
- Initiated by the company
- Nov 24, 2021
- Recalling firm
- Reflexion Medical, Inc.
- Quantity
- 3 devices
- Product code
- IYE
- FDA submissions
- K190978
- Distribution
- U.S. Nationwide distribution in the states of CA and TX
Product description
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Reflexion Medical Radiotherapy System RXM1000Reflexion Medical, Inc. · Accelerator, Linear, Medical1 recall2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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