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U.S. Department of Health and Human Services

Class 2 Device Recall Interplant

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  Class 2 Device Recall Interplant see related information
Date Initiated by Firm December 01, 2008
Date Posted June 23, 2011
Recall Status1 Terminated 3 on April 04, 2013
Recall Number Z-2622-2011
Recall Event ID 58228
510(K)Number K982696  
Product Classification System, Planning, Radiation Therapy Treatment - Product Code MUJ
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.
Code Information Interplant Release 3.4.0
Recalling Firm/
Manufacturer		 Computerized Medical Systems Inc
13723 Riverport Drive
Suite 100
Maryland Heights MO 63043
For Additional Information Contact Christopher Ivicevich
408-380-8023
Manufacturer Reason
for Recall		 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 t
FDA Determined
Cause 2		 Software design
Action Computerized Medical Systems, Inc. sent a "CUSTOMER ADVISORY" letter dated December 1, 2008, to all affected customers. The letter identified the product, the problem, and the actions to be taken. Customers were instructed to discontinue use of the product. There is no workaround at this time. This issue was resolved in Interplant Release 3.4.1 software. All possibly affected users have been shipped the Interplant Release 3.4.1 software in May 2010. If you have any questions, please call 314-993-0003 or toll free 800-878-4267.
Quantity in Commerce 41
Distribution Worldwide Distribution -- USA (nationwide) including states of: CA, KS, KY, MA, MD, ME, MO, NC, NE, NY, OH, PA, TX and VA and countries of: Australia, Brazil, Chile, China, Germany and Japan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = BURDETTE MEDICAL SYSTEMS, INC.
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