MEVION S250i, MEVION S250; Proton Radiation Treatment System
- Company
- Mevion Medical Systems, Inc.
- Recall Initiated
- May 15, 2020
- Terminated
- December 11, 2020
- Recall Number
- Z-2406-2020
- Quantity
- 8 units
- Firm Location
- Littleton, MA
Reason for Recall
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
Distribution
Distribution to US in MO, NJ, OH, OK, FL, and DC, and the Netherlands
Lot / Code Info
Serial Numbers: MEVION S250-0001 MEVION S250-0002 MEVION S250-0003 MEVION S250-0004 MEVION S250-0005 MEVION S250-0006 MEVION S250-0007 MEVION S250-0008 UDI: (01)00864366000100 (11) 131209 (01)00864366000100 (11)150526 (01)00864366000100 (11)150113 (01)00864366000100 (11)150430 (01)00864366000100 (11)160127 (01)00864366000100 (11)160603 (01)00864366000124 (11) 180220 (01)00864366000124 (11) 181219
Root Cause
Software design
Action Taken
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.