Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with
FDA device recall Z-1237-2015 · posted 2015-03-02 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Incorrect CT to ED when using the Monaco Image Statistics Tool.
- Action taken
- Elekta sent an Important User Notice on December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This notice provided a workaround until new software releases. The notice included a acknowledgement form to be returned. For further questions please call (770) 300-9725
- Root cause
- Other
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 1354
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AK, AZ, CA, CO, CT, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MT, NH, NJ, NM, NY, NC, ND, OH,
- Date initiated
- 2014-12-19
- Date posted
- 2015-03-02
- Date terminated
- 2017-11-17
- 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 (K132971) | Impac Medical Systems, Inc. | 2013-11-20 |