Recall Z-1365-2012 ยท MUJ System, Planning, Radiation Therapy Treatment
Computerized Medical Systems Inc
Monaco Radiation Treatment Planning System, Version 3.10.00. Planning of radiation therapy.
| Date | Apr 3, 2012 (initiated Mar 5, 2012) |
| Status | Terminated |
| Reason | An unnecessary dose refresh can occur in certain situations which causes inconsistencies in the Beam Doses and the Total Dose. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 44 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110730 | MONACO RTP SYSTEM Computerized Medical Systems, Inc., Jun 24, 2011 |