RefleXion Medical Radiotherapy System Recall Due to Dose Discrepancy
Reflexion Medical is recalling three RefleXion X1 radiotherapy systems due to a potential dose discrepancy when delivering treatment in Feet First Supine patient orientation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a medical device with potential for patient harm through incorrect radiation dosing, but no illnesses, injuries, or deaths have been reported. Per the rubric, when no illnesses/injuries are reported and the hazard is theoretical, the score is at most 3. The risk of dose discrepancy in radiotherapy qualifies as a high-risk condition absent any reported harm.
Plain-English summary
Reflexion Medical, Inc. is recalling three RefleXion X1 Model RXM1000 radiotherapy systems (Serial Numbers X11001, X11002, X11003) that were distributed in California and Texas. The recall was issued because the devices may deliver incorrect radiation doses when treatment plans are delivered to patients positioned in Feet First Supine (FFS) orientation, rather than the intended Head First Supine (HFS) orientation.
The dose discrepancy occurs specifically with FFS patient positioning and could result in incorrect radiation dosing during cancer treatment. No illnesses or injuries have been reported in connection with this issue.
Healthcare facilities and medical professionals using these affected radiotherapy systems should contact Reflexion Medical, Inc. immediately for guidance on patient positioning verification and treatment plan review procedures to ensure proper dose delivery.
The recalled product
- Product
- RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
- Manufacturer
- Reflexion Medical, Inc.
- Affected units
- 3
Distribution
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