| Class 2 Device Recall MEVION S250i, MEVION S250; Proton Radiation Treatment System | |
Date Initiated by Firm | May 15, 2020 |
Create Date | June 22, 2020 |
Recall Status1 |
Terminated 3 on December 11, 2020 |
Recall Number | Z-2406-2020 |
Recall Event ID |
85748 |
510(K)Number | K120676 K172848 |
Product Classification |
System, radiation therapy, charged-particle, medical - Product Code LHN
|
Product | MEVION S250i, MEVION S250; Proton Radiation Treatment System |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Mevion Medical Systems, Inc. 300 Foster St Littleton MA 01460-2017
|
For Additional Information Contact | Ping Hu 978-540-1500 |
Manufacturer 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 |
FDA Determined Cause 2 | Software design |
Action | 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. |
Quantity in Commerce | 8 units |
Distribution | Distribution to US in MO, NJ, OH, OK, FL, and DC, and the Netherlands |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = LHN
|
|
|
|