FDAFDA · Food and drugs·Recall number Z-0767-2016
MEVION S250 Radiation therapy system
Published February 17, 2016 · Recall initiated: November 18, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mevion Medical Systems, Inc.
- Distributor
- US nationwide distribution including FL, NJ, OK, and MO.
- Lot
- Manufacturing Lot or Serial Number: S250-0004
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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