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U.S. Department of Health and Human Services

Class 2 Device Recall MEVION S250/MEVION S250i

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  Class 2 Device Recall MEVION S250/MEVION S250i see related information
Date Initiated by Firm June 29, 2018
Create Date August 11, 2018
Recall Status1 Terminated 3 on October 02, 2018
Recall Number Z-2746-2018
Recall Event ID 80615
510(K)Number K120676  K172848  
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
Product MEVION S250/MEVION S250i Proton Beam Radiation therapy system


Product Usage:
Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.
Code Information S250-0001 through S250-0006 and S250i-0007
Recalling Firm/
Manufacturer		 Mevion Medical Systems, Inc.
300 Foster St
Littleton MA 01460-2017
For Additional Information Contact Mr. Rob Cessac
636-485-4962
Manufacturer Reason
for Recall		 QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch consists of a precision latch mechanism that can be damaged when used with incompatible (third-party) accessories. This can create unsafe conditions for use and may compromise the subsequent use of any kVue inserts, whether authorized or not. Use of unauthorized or unvalidated inserts may lead to an incorrect patient treatment or physical injury.
FDA Determined
Cause 2		 Device Design
Action On June 29, 2018, the firm sent out a User Notice to consignees to alert customers to the Advisory Notice issued by QFix regarding the use of an Orfit HP Pro Solution combined with the QFix kVue couch top. Customers using third-party inserts are advised to immediately inspect the latching mechanism for damage and contact the third-party insert vendor for advice on the use of the insert and confirmation of compatibility. Mevion will update user manuals to include the following warning about using alternative third party vendor inserts: WARNING: Interchangeable Couch Top inserts are integral to the immobilization, treatment beam planning, and physical safety of each patient. Use of unauthorized or unvalidated inserts may lead to an incorrect patient treatment or physical injury. Only use Mevion-provided accessories or devices that are confirmed by the third party suppliers to be compatible with the Mevion Couch for safe and effective patient treatment. Please contact Rob Cessac at rcessac@mevion.com or call 636-485-4962 for any questions or concerns.
Quantity in Commerce 7
Distribution US Nationwide Distribution in the states of DC, FL, MO, NJ, OH, and OK.
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
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