Z-0705-2019Class II

MEVION S250i

Name: Z-0705-2019 MEVION S250i
Creator: Mevion Medical Systems, Inc.
Published: 2018-10-01
License: https://open.fda.gov/license/

Mevion Medical Systems, Inc. / initiated 2018-10-01 / Terminated / root cause: software

FDA source

Mevion Medical Systems, Inc. began a recall of MEVION S250i on 2018-10-01. FDA classified it as Class II and gives the reason as "Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0705-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-01
Posted: 2019-01-09
Terminated: 2020-04-10
Recalling firm: Mevion Medical Systems, Inc.
Product: MEVION S250i
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: On-site Mevion Field Service Engineer communicated with the firm and is in daily communication with the single affected consignee.
Quantity in commerce: 1 unit
Distribution: DC
Product codes and lots: DI: (01)00864366000124 Serial Number: S250i-0007

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0705-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0705-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-16	2019-01-09

Product code LHN

K172848Class IIMEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems / cleared 2017-12-27

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)