Z-0767-2016Class II

MEVION S250 Radiation therapy system

Name: Z-0767-2016 MEVION S250 Radiation therapy system
Creator: Mevion Medical Systems, Inc.
Published: 2015-11-18
License: https://open.fda.gov/license/

Mevion Medical Systems, Inc. / initiated 2015-11-18 / Terminated / root cause: labeling and UDI

FDA source

Mevion Medical Systems, Inc. began a recall of MEVION S250 Radiation therapy system on 2015-11-18. FDA classified it as Class II and gives the reason as "The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0767-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-18
Posted: 2016-02-08
Terminated: 2017-04-03
Recalling firm: Mevion Medical Systems, Inc.
Product: MEVION S250 Radiation therapy system
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Customer notification letter was sent via certified mail on November 18, 2015. The notification explains the issue and actions to be taken by the customer.
Quantity in commerce: 4
Distribution: US nationwide distribution including FL, NJ, OK, and MO.
Product codes and lots: Manufacturing Lot or Serial Number: S250-0004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0767-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0767-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-08

Product code LHN

K120676Class IIS-250 Proton Beam Radiation Therapy SystemMevion Medical Systems / cleared 2012-06-04

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)