Z-2746-2018Class II

MEVION S250/MEVION S250i Proton Beam Radiation therapy system

Name: Z-2746-2018 MEVION S250/MEVION S250i Proton Beam Radiation therapy system
Creator: Mevion Medical Systems, Inc.
Published: 2018-06-29
License: https://open.fda.gov/license/

Mevion Medical Systems, Inc. / initiated 2018-06-29 / Terminated / root cause: design

FDA source

Mevion Medical Systems, Inc. began a recall of MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with... on 2018-06-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2746-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-29
Posted: 2018-08-11
Terminated: 2018-10-02
Recalling firm: Mevion Medical Systems, Inc.
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.
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
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.
Root cause tag: design
FDA root cause: 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 [email protected] 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.
Product codes and lots: S250-0001 through S250-0006 and S250i-0007

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2746-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2746-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-10

Product code LHN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)