Mevion Medical Systems, Inc. MEVION S250i, MEVION S250; Proton Radiation Treatment System Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off

Recommended Action

Per FDA guidance

Mevion issued letter (pCAR0012) on May 15, 2020 via mail or FedEx, with return receipt confirmation. Letter states reason for recall, health risk and action to take: Until a software fix is applied for this problem, the user is cautioned to carefully pay attention to the 3 indicators of Couch corrections. If they disagree with the intended moves the user may simply repeat the alignment step and the problem should clear. Required User Action When using multimodal imaging the user should always check the indicators for Couch Corrections before they are applied. This includes the Verity Couch Correction widget, the Verity dialog box the informs the user of the actions being sent to the Couch, and the In Room Monitor lower right panel that displays the moves before they are made. If these disagree with the intended moves, the user should back up a step and resend the corrections. Users must confirm positioning for every applied Couch correction that all intended moves are indicated and made.

Distribution

As reported by FDA

FL, IN, MO, NJ, OH, OK, DC