Recall Z-0470-2022— Reflexion Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Reflexion Medical, Inc., initiated 2021-11-24, terminated 2024-07-08. It names one FDA 510(k) clearance: K190978. Product: RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000". Reason: 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)..
- Recalling firm
- Reflexion Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-11-24
- Terminated
- 2024-07-08
- Firm location
- Hayward, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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"
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.