Monaco Radiation Treatment Planning Workstation. Monaco Release 2.04.00 and above. Used to create treatment plans for an
FDA device recall Z-2569-2011 · posted 2011-06-15 · Terminated
Recall details
- Recalling firm
- Computerized Medical Systems Inc
- Reason for recall
- Monaco: In XiO IMRT (Dynamic MLC Delivery) software, the radiation beam angle is set to zero. If different beam angles are selected via Monaco software, the beam angles will remain at zero.
- Action taken
- Computerized Medical Systems, Inc. sent a User Notice to the affected consignees on October 27, 2010, explaining the reason for correction, the clinical impact, and the workaround method. (VERIFY USE NOTICE DATE) A return postcard was included for the customer to confirm receipt of the User Notice. The firm intends for this issue to be corrected in Monaco Release 3.00 in March 2011.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 11
- Distribution
- Worldwide Distribution - USA including CA, IL, MN, NM, OH, NY, TX, and WA and the Netherlands.
- Date initiated
- 2010-10-27
- Date posted
- 2011-06-15
- Date terminated
- 2014-04-02
- 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 |