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Open, Classified

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

FDA Recall Z-0827-2022 · Posted None

Recalling FirmMevion Medical Systems, Inc.
Recall StatusOpen, Classified
Product CodeLHN
Date Initiated2022-02-01
Product Quantity39 (36 US, 3 OUS)

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.

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172848MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems · 2017-12-27K120676S-250 PROTON BEAM RADIATION THERAPY SYSTEMMevion Medical Systems · 2012-06-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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