Nucletron Radiation Therapy Software Class II

Nucletron Plato External Beam Planning Radiation Therapy SoftwareV2.1.2 and MLC/Shape Software Module V2.3

Recall #Z-038-0.

REASON

Coordinates for radiation beam used in therapy are mislabeled in
software.

CODE

Plato RTS software version V2.1.2 used with software module
MLC/Shape version V2.3.

MANUFACTURER

Nucletron BV, The Netherlands.

RECALLED BY

Nucletron Corporation, Columbia, Maryland, by letter and customer
information bulletin sent on August 10, 1999. Firm-initiated
field correction ongoing.

DISTRIBUTION

Ohio and Mexico.

QUANTITY

31 copies of software were distributed.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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