Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0827-2022 — Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)

U.S. FDA — Device Enforcement · United States · 2022-02-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0827-2022
Date of alert
2022-02-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Mevion Medical Systems, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00864366000100
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.