Monaco Radiation Treatment Planning System, Version 3.10.00. Planning of radiation therapy.
This recall has been terminated (originally issued April 3, 2012).
- Company
- Computerized Medical Systems Inc
- Recall Initiated
- March 5, 2012
- Posted
- April 3, 2012
- Terminated
- April 1, 2014
- Recall Number
- Z-1365-2012
- Quantity
- 44
- Firm Location
- Maryland Heights, MO
- Official Source
- View on FDA website ↗
Reason for Recall
An unnecessary dose refresh can occur in certain situations which causes inconsistencies in the Beam Doses and the Total Dose.
Distribution
Worldwide Distribution -- USA, including the states of OH, IN, WI, CA, FL, IL, LA, NJ, MA, NC, and MO and the countries of Canada, Australia, Belgium, China, France, Germany, Japan, The Netherlands, New Zealand, Portugal, Switzerland, Taiwan, and the United Kingdom.
Lot / Code Info
Version 3.10.00
Root Cause
Software design
Action Taken
An "IMPORTANT SAFETY NOTICE" was issued between 3/5-9/12 via e-mail, FAX, or traditional mail. The Notice described the correct functioning of the system, the problem, when and why the issue occurs, the clinical impact, and the workaround. Patch 3.10.01 is now available. Customers can download their patch at the link provided in the Notice. The Notice also provided a list of offices where customers can contact if they have questions or further support is needed.