Z-0827-2022Class II

Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)

Name: Z-0827-2022 Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Creator: Mevion Medical Systems, Inc.
Published: 2022-02-01
License: https://open.fda.gov/license/

Mevion Medical Systems, Inc. / initiated 2022-02-01 / Open, Classified / root cause: design

FDA source

Mevion Medical Systems, Inc. began a recall of Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808) on 2022-02-01. FDA classified it as Class II and gives the reason as "Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0827-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-01
Posted: 2022-03-25
Recalling firm: Mevion Medical Systems, Inc.
Product: Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room.
Root cause tag: design
FDA root cause: Component design/selection
Action: Mevion has voluntarily recalled Hand Pendants for S250 and S250i Proton Therapy Systems. All distributed Hand Pendants have been inspected for the identified defect and those that failed inspection have been removed from service following technical service bulletin TSB0048. Subsequent Urgent Medical Device Recall Notice dated 02/11/2022 was hand delivered by on-site field service engineers. Customers are instructed to complete and return the acknowledgement receipt. Please contact Mevion Customer service ([email protected]) with any questions or concerns.
Quantity in commerce: 39 (36 US, 3 OUS)
Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands.
Product codes and lots: All theryapy systems, all hand pendant serial numbers. Therapy system UDI 00864366000100 and UDI 00864366000124.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0827-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0827-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-06	2022-03-25

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)