Z-0409-2017Class II

Mevion S250

Name: Z-0409-2017 Mevion S250
Creator: Mevion Medical Systems, Inc.
Published: 2016-10-31
License: https://open.fda.gov/license/

Mevion Medical Systems, Inc. / initiated 2016-10-31 / Terminated / root cause: software

FDA source

Mevion Medical Systems, Inc. began a recall of MEVION S250 Product Usage: Proton Radiation Therapy on 2016-10-31. FDA classified it as Class II and gives the reason as "Completing Setup Without Program Move Complete Can Cause An Isocenter Error". 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-0409-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-31
Posted: 2016-11-15
Terminated: 2017-06-29
Recalling firm: Mevion Medical Systems, Inc.
Product: MEVION S250 Product Usage: Proton Radiation Therapy
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Completing Setup Without Program Move Complete Can Cause An Isocenter Error
Root cause tag: software
FDA root cause: Software design
Action: Mevion issued an Important Safety Notice letter on October 31, 2016 to customers. The identified the affected product, problem, mitigation and advisory information. The letter informed customers that Mevion will release and install a software patch that removes the reliance on tracking isocenter changes for the correct reporting of the Couch position to the user displays and to the OIS. For further information mailto:[email protected]
Quantity in commerce: 6 units
Distribution: US Nationwide in the states of FL, MO, NJ and OK
Product codes and lots: Serial NUmbers: S250-0001 through S250-0006

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0409-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0409-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-14

Product code MUJ

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)