10
Aug
1999

Nucletron Radiation Therapy Software Class II

0

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.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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