Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.
FDA device recall Z-2277-2013 · posted 2013-09-25 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Patient needs to be positioned as indicated by the treatment plan.
- Action taken
- Computerized Medical Systems issued an Important Safety Notice dated May 22, 2013 to all affected customers. This letter idenitfies the problems the products and the actions needed to be takem by the custom.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 72
- Distribution
- Distributed in Puerto Rico and the states of AK, AZ, CA, CO, CT, FL, IL, IN, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, and WA.
- Date initiated
- 2013-05-22
- Date posted
- 2013-09-25
- Date terminated
- 2013-12-23
- Location
- Atlanta, GA
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 |