MEVION S250 for Proton Radiation Therapy
Reported: April 27, 2016 Initiated: March 15, 2016 #Z-1529-2016
Product Description
MEVION S250 for Proton Radiation Therapy
Reason for Recall
Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture may fall out during Gantry motion. It is possible that it can hit a patient and cause traumatic injury or death.
Details
- Recalling Firm
- Mevion Medical Systems, Inc.
- Units Affected
- 5
- Distribution
- US nationwide distribution to MO, OK, FL, and NJ.
- Location
- Littleton, MA
Frequently Asked Questions
What product was recalled? ▼
MEVION S250 for Proton Radiation Therapy. Recalled by Mevion Medical Systems, Inc.. Units affected: 5.
Why was this product recalled? ▼
Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture may fall out during Gantry motion. It is possible that it can hit a patient and cause traumatic injury or death.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 27, 2016. Severity: Moderate. Recall number: Z-1529-2016.
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