Monaco Radiation Treatment Planning Workstation, Monaco Release 2.03.00 and above To create treatment plans for any canc
FDA device recall Z-2598-2011 · posted 2011-06-20 · Terminated
Recall details
- Recalling firm
- Computerized Medical Systems Inc
- Reason for recall
- Monaco: When the isocenter location is edited in the IMRT Activity screen, the shift coordinates are not updated in the IMRT Plan report.
- Action taken
- Computerized Medical Systems Inc drafted a User Notice which explains the reason for correction, the clinical impact, and the workaround method. The User Notice was sent January 13, 2011. A return postcard is 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
- 137
- Distribution
- Worldwide Distribution - USA (Nationwide distribution to AK, AZ, CA, CO, FL, IL, IN, MA, MI, MN, MO, NC, NM, NY, OH, OR, PA, SC, TX, VA, WA, and WI and the countries of Algeria, Australia, Austria, Be
- Date initiated
- 2011-01-13
- Date posted
- 2011-06-20
- 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 |