Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MEVION S250i, MEVION S250; Proton Radiation Treatment System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall MEVION S250i, MEVION S250; Proton Radiation Treatment System see related information
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 K172848  K120676  
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 and Original Applicant = MEVION MEDICAL SYSTEMS
-
-