Reflexion Medical recalls RXM1000 radiotherapy systems due to dose discrepancies when treating patients in Feet First Supine (FFS) positions. Affected units have specific serial numbers and model labels.
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).
Reflexion Medical is recalling its RXM1000 radiotherapy systems because they can deliver incorrect radiation doses when treating patients in a Feet First Supine (FFS) position. This could lead to improper treatment and potential health risks if not corrected.
The system may deliver incorrect radiation doses when treating patients in a Feet First Supine (FFS) orientation. This dose discrepancy could result in improper treatment and potential health risks if the error is not corrected.
Healthcare providers using the RefleXion RXM1000 radiotherapy system for cancer treatment are most at risk. Patients receiving treatment in Feet First Supine positions may be affected.
Check for the system label: "*** refleXion REF RXM1000 ***" on the device. Affected units have specific serial numbers starting with X11001, X11002, or X11003.
Look for the label: "*** refleXion REF RXM1000 ***" on the device.
The system may deliver incorrect radiation doses when treating patients in Feet First Supine (FFS) positions.
Check for the system label: "*** refleXion REF RXM1000 ***" and serial numbers starting with X11001, X11002, or X11003.
The recall record does not specify a remedy, so contact Reflexion Medical directly for guidance.
We’ve drafted a message you can send Reflexion Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0470-2022 — Reflexion Medical Reflexion Medical Hello, I own a Reflexion Medical that is covered by recall Z-0470-2022 from Reflexion Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
