MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation
Reported: December 2, 2020 Initiated: October 19, 2020 #Z-0485-2021
Product Description
MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation
Reason for Recall
Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur
Details
- Recalling Firm
- Mevion Medical Systems, Inc.
- Units Affected
- 8 units
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of DC, FL, MO, NJ, OK and the country of Netherlands.
- Location
- Littleton, MA
Frequently Asked Questions
What product was recalled? ▼
MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation. Recalled by Mevion Medical Systems, Inc.. Units affected: 8 units.
Why was this product recalled? ▼
Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 2, 2020. Severity: Moderate. Recall number: Z-0485-2021.
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