Hand Pendant Malfunction in Proton Therapy Systems Poses Patient Injury Risk
Mevion S250 and S250i Proton Therapy Systems hand pendants may malfunction, causing unintended motion of the therapy couch and nozzle. This poses a risk of patient injury if they contact moving equipment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a medical device with potential for patient injury through uncontrolled motion of therapy equipment. The source describes a risk-of-harm scenario without reported injuries or deaths, meeting the rubric criterion for score 3.
Plain-English summary
The U.S. Food and Drug Administration is recalling Mevion S250 and S250i Proton Therapy Systems hand pendants (part numbers 10263 and 37808). The hand pendant is used to control movement of the therapy couch and nozzle during proton beam cancer treatment.
The hand pendants may malfunction, resulting in unintended motion of the therapy couch and nozzle. If a patient comes into contact with the moving nozzle or other objects in the treatment room during this malfunction, they could be injured.
This recall affects 39 hand pendants worldwide, with 36 located in the United States and 3 in the Netherlands. In the U.S., affected devices are distributed to facilities in Florida, Missouri, New Jersey, Ohio, Oklahoma, Utah, and the District of Columbia.
Facilities with affected hand pendants should contact Mevion Medical Systems, Inc. for further information and instructions regarding repair or replacement.
The recalled product
- Product
- Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
- Manufacturer
- Mevion Medical Systems, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All theryapy systems
Distribution
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