Mevion Medical Systems, Inc.: MEVION S250i, MEVION S250; Proton Radiation Treatment System

Is my product affected?

MEVION S250i, MEVION S250; Proton Radiation Treatment System

• 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 distributed to facilities in Missouri, New Jersey, Ohio, Oklahoma, Florida, Washington D.C., and the Netherlands. The systems have a software defect where couch correction movements sent after using a 3D CT scan are partially lost if the previous correction had some of the couch correction checkboxes turned off.

The recall affects eight specific units identified by serial numbers MEVION S250-0001 through MEVION S250-0008. The source document does not specify what remedy consumers should take or what steps they should follow in response to this recall.

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

Hazard

Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off

Details from the source

Reason for recall: Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off Distribution: Distribution to US in MO, NJ, OH, OK, FL, and DC, and the 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.

Related recalls

• (1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage: are clinical laboratory information modules which consolidate test orders and tes2020-05-15
• (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager software version 1.1 Siemens Material Number (SMN): 11316888 Product Usage: are clinical laboratory information modules which consolidate test orders and test results, provide test orderi2020-05-15
• 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.2020-05-15
• 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.2020-05-15
• PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.2020-05-15

All FDA (Device enforcement) recalls