MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Reported: July 29, 2020 Initiated: June 23, 2020 #Z-2686-2020
Product Description
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Reason for Recall
The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer.
Details
- Recalling Firm
- Mevion Medical Systems, Inc.
- Units Affected
- 8 units
- Distribution
- MO, NJ, OK, FL, OH, DC, Netherlands
- Location
- Littleton, MA
Frequently Asked Questions
What product was recalled? ▼
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients. Recalled by Mevion Medical Systems, Inc.. Units affected: 8 units.
Why was this product recalled? ▼
The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 29, 2020. Severity: Moderate. Recall number: Z-2686-2020.
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