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Recall Observatory FDA recall evidence

Device product

MEVION S250 Radiation therapy system

Z-0767-2016

November 18, 2015

Class II

Product summary

Firm
Mevion Medical Systems, Inc.
Event
Event 72210
Status
Terminated
Classification
Class II
Quantity
4
Official record key
device-enforcement:Z-0767-2016

Official wording

Reason: The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment.

Code information: Manufacturing Lot or Serial Number: S250-0004

Distribution pattern: US nationwide distribution including FL, NJ, OK, and MO.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment.