Monaco Radiation Treatment Planning System, Version 3.10.00. Planning of radiation therapy.
FDA device recall Z-1365-2012 · posted 2012-04-03 · Terminated
Recall details
- Recalling firm
- Computerized Medical Systems Inc
- Reason for recall
- An unnecessary dose refresh can occur in certain situations which causes inconsistencies in the Beam Doses and the Total Dose.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 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, N
- Date initiated
- 2012-03-05
- Date posted
- 2012-04-03
- Date terminated
- 2014-04-01
- 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 (K110730) | Computerized Medical Systems, Inc. | 2011-06-24 |