Mevion Medical Systems, Inc.: MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients

Is my product affected?

MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients

• UPC 00864366000100
• UPC 00864366000124

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

What happened

Mevion Medical Systems, Inc. is recalling eight units of the MEVION S250 Proton Radiation Treatment System distributed in Missouri, New Jersey, Oklahoma, Florida, Ohio, Washington D.C., and the Netherlands. The recall addresses a hazard involving the perforated screen inside the process water tank, which has a very sharp edge across the top of the Heat Exchanger that could potentially injure service technicians.

The affected units are identified by lot numbers MEVION S250-0001 through MEVION S250-0008 with various manufacturing dates ranging from December 2013 through December 2019. The recall document does not specify a remedy or recommended course of action for affected consumers.

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

Hazard

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 from the source

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. Distribution: MO, NJ, OK, FL, OH, DC, Netherlands Quantity: 8 units Lot/code info: Lot #s: 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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