Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. The Monaco RTP system is used to crea
FDA device recall Z-2561-2011 · posted 2011-06-14 · Terminated
Recall details
- Recalling firm
- Computerized Medical Systems Inc
- Reason for recall
- Monaco: For VMAT plans, the measured dose of radiation delivered is lower than the software calculated dose by about 5% in Monaco Release 2.03.00 and 2.04.00.
- Action taken
- Computerized Medical Systems, Inc. sent a "USER NOTICE" on January 13, 2011, to all affected users. This notice identified the product, the problem, and the action needed to be taken by the customer. A return postcard is included for the customer to confirm receipt of the user notification. The firm intends for correction in the dose calulation engine to appear in the Monaco Release 3.00 in March 2011. Any further questions please call (403) 830-8023.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 94
- Distribution
- Worldwide Distribution-- USA (nationwide) and countries of Austria, Australia, Belarus, Canada, China, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, India, Israel, Italy,
- Date initiated
- 2011-01-13
- Date posted
- 2011-06-14
- Date terminated
- 2014-04-03
- Location
- Maryland Heights, MO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MONACO RTP SYSTEM, VMAT OPTION (K091179) | Computerized Medical Systems, Inc. | 2009-07-16 |
| MONACO RTP SYSTEM (K071938) | Computerized Medical Systems, Inc. | 2007-10-01 |