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.
- Company
- Mevion Medical Systems, Inc.
- Recall Initiated
- June 29, 2018
- Terminated
- October 2, 2018
- Recall Number
- Z-2746-2018
- Quantity
- 7
- Firm Location
- Littleton, MA
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.
Distribution
US Nationwide Distribution in the states of DC, FL, MO, NJ, OH, and OK.
Lot / Code Info
S250-0001 through S250-0006 and S250i-0007
Root Cause
Device Design
Action Taken
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.