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.
This recall has been terminated (originally issued June 23, 2011).
- Company
- Computerized Medical Systems Inc
- Recall Initiated
- December 1, 2008
- Posted
- June 23, 2011
- Terminated
- April 4, 2013
- Recall Number
- Z-2622-2011
- Quantity
- 41
- Firm Location
- Maryland Heights, MO
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
Interplant Release 3.4.0
Root Cause
Software design
Action Taken
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.