Use cautionMedical device recall · FDA · Published February 1, 2022
Mevion S250 Hand Pendant Recall: Unintentional Motion Risk
Mevion recalls S250 and S250i proton therapy hand pendants with risk of unintended motion causing patient injury. Affected units have specific serial numbers and UDI codes.
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.
Take action
Contact the company
📍Recalling firmMevion Medical Systems, Inc.300 Foster St · Littleton, MA 01460-2017
✎ GovInfoNow plain-language explainer
Mevion is recalling hand pendants for proton therapy systems that could move unintentionally during treatment, potentially causing injury to patients. This recall affects specific models and serial numbers used in cancer treatment facilities. Read more at govinfonow.com/recall/61193-mevion-s250-hand-pendant-recall-unintentional-motion-risk.
“Mevion S250 Hand Pendant Recall: Unintentional Motion Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61193-mevion-s250-hand-pendant-recall-unintentional-motion-risk. Based on FDA recall #Z-0827-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0827-2022%22&limit=1).
The FDA announced on Feb. 1, 2022, that Mevion Medical Systems, Inc. is recalling Mevion S250 and S250i Proton Therapy Systems hand pendants due to malfunction risks. The agency stated the recall is voluntary and ongoing.
How to tell if you have it
Brand: Mevion
Product: Mevion S250 and S250i Proton Therapy Systems hand pendant
Part Number: P/N 10263 or P/N 37808
UDI: 00864366000100 and UDI 00864366000124
The hazard
According to the FDA, a 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.
Context
GovInfoNow's records show Mevion Medical Systems, Inc. has had five other recalls since June 29, 2018. Other recent recalls of similar products include Canon Alphenix INFX-8000H X-ray System Recall (Dec. 19, 2025), Canon Alphenix INFX-8000C X-ray System Recall (Dec. 19, 2025), and Merit Medical Custom Procedure Kit Recall (Dec. 4, 2025).
How to tell if you have this one
Check for hand pendants with serial numbers P/N 10263 or P/N 37808. The therapy system UDI codes 00864366000100 and 00864366000124 are also affected.
Brand
Mevion
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Hand Pendant Serial Numbers
Look for serial numbers P/N 10263 or P/N 37808 on the hand pendant.
Contact Facility for Verification
Confirm if your therapy system has the affected UDI codes 00864366000100 or 00864366000124.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 6 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: District of Columbia, Florida, Missouri, New Jersey, Ohio, Oklahoma, Utah.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0827-2022 (February 1, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0827-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.