Mevion Medical Systems, Inc.: MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any othe

Is my product affected?

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

• UPC 00864366000100
• UPC 00864366000124

Check against the official notice below — it lists the full affected range.

What happened

Mevion Medical Systems is recalling eight MEVION S250i and MEVION S250 proton radiation treatment systems due to a malfunction where treatment beam information disappears from the Treatment Console screen while radiation beam delivery continues. This malfunction could potentially harm patients receiving proton radiation therapy for localized tumors. The affected units have specific serial numbers ranging from MEVION S250-0001 through MEVION S250-0008 and were distributed worldwide, including locations in Florida, Missouri, New Jersey, Oklahoma, Washington D.C., and the Netherlands.

The recall notice does not specify a remedy or corrective action for affected consumers to take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur

Details from the source

Reason for recall: Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur Distribution: Worldwide distribution - US Nationwide distribution including in the states of DC, FL, MO, NJ, OK and the country of Netherlands. Quantity: 8 units Lot/code info: Serial Numbers: MEVION S250-0001 MEVION S250-0002 MEVION S250-0003 MEVION S250-0004 MEVION S250-0005 MEVION S250-0006 MEVION S250-0007 MEVION S250-0008 UDI: 01)00864366000100 (11) 131209 (01)00864366000100 (11)150526 (01)00864366000100 (11)150113 (01)00864366000100 (11)150430 (01)00864366000100 (11)160127 (01)00864366000100 (11)160603 (01)00864366000124 (11) 180220 (01)00864366000124 (11) 181219

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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