MEVION S250 Product Usage: Proton Radiation Therapy System
Reported: November 23, 2016 Initiated: October 20, 2016 #Z-0411-2017
Product Description
MEVION S250 Product Usage: Proton Radiation Therapy System
Reason for Recall
Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter
Details
- Recalling Firm
- Mevion Medical Systems, Inc.
- Units Affected
- 6 units
- Distribution
- US Nationwide Distribution in the states of: FL, MO, NJ, OH, OK
- Location
- Littleton, MA
Frequently Asked Questions
What product was recalled? ▼
MEVION S250 Product Usage: Proton Radiation Therapy System. Recalled by Mevion Medical Systems, Inc.. Units affected: 6 units.
Why was this product recalled? ▼
Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 23, 2016. Severity: Moderate. Recall number: Z-0411-2017.
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