04

Aug

2011

Cl ll Interplant Radiation Treatment Planning Sys

0

Company:Computerized Medical Systems Inc.
Date of Enforcement Report 8/3/11
Class ll:

PRODUCT
Interplant Radiation Treatment Planning System, Interplant Release 3.4.0 Used when planning and performing prostate brachytherapy implant procedure. It provides ultrasound probe alignment and radioactive seed implantation. Recall # Z-2622-2011

REASON
Interplant Software: If the trajectory needle with a non-zero retraction is adjusted in any of the planning views (Transverse, 3D) and the program is closed and reopened, the Needle Definitions page in the Dose Plan Summary (Plan View) displays the needle with a 0.00 retraction even when the needle is displayed correctly in the planning view. If the Eliminate Leading Spacers function is applied to a needle with an adjusted trajectory, the first seed is adjusted to the 0.00 cm plane instead of adjusting the retraction to the position of the first seed.

RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter dated December 1, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
41 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

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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