RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
FDA Recall Z-0470-2022 · Posted None
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Recalling FirmReflexion Medical, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2021-11-24
Date Terminated2024-07-08
Product Quantity3 devices
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).
Firm 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]
Root Cause
Software design
Distribution Pattern
U.S. Nationwide distribution in the states of CA and TX
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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