Recall Z-2564-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Computerized Medical Systems Inc
Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 and above Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed.
| Date | Jun 14, 2011 (initiated May 31, 2010) |
| Status | Terminated |
| Reason | Monaco: due to a software defect, the Radiological Depth (cm) and SSD to DRP (cm) parameters are reported incorrectly on the Beam Summary Report. This occurs for all Monaco IMRT plans. |
| Root cause | Software design |
| Action | Computerized Medical System sent a "USER NOTICE" letter dated June 24, 2010, to all affected users. This notice identified the product, the problem, and the actions to be taken. There is no current workaround. All customers will be mailed a postcard to be returned as proof of receipt and understanding of the notification. Consignees will be contact via telephone or e-mail after June 30, 2010 if the postcard is not returned This notice is to be distributed to any and all users of CMS software at your organization who are potentially affected. The notice states the issue will be resolved in |
| Quantity | 62 |
| Distribution | Worldwide Distribution -- USA (nationwide) and the countries of Australia, Austria, Belgium, China, Finland, France, Germany, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, Switzerland, Taiwan, Thailand and United Kingdom. |
| FDA record | Open on fda.gov |