| Date Initiated by Firm | February 11, 2013 |
|---|
| Date Posted | February 20, 2013 |
|---|
| Recall Status1 |
Terminated 3 on January 21, 2014 |
| Recall Number | Z-0841-2013 |
|---|
| Recall Event ID |
64328 |
| 510(K)Number | K110730 |
|---|
| Product Classification |
System, planning, radiation therapy treatment - Product Code MUJ
|
| Product | Monaco RTP System.
Radiation treatment planning. |
|---|
| Code Information |
Versions 3.20.00 and 3.20.01 |
| FEI Number |
1037831
|
Recalling Firm/
Manufacturer |
Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta GA 30346-1227
|
| For Additional Information Contact | Chris Ivicevich
408-830-8023 |
|---|
Manufacturer Reason
for Recall | The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle. |
|---|
FDA Determined
Cause 2 | Nonconforming Material/Component |
|---|
| Action | Elekta provided customers with an "Important Safety Notice - Dose Display Not Matching Beam Geometry - Monaco RFC 35748". The notice identified the product, problem, and actions to be taken by the customers. Contact the form at 800-878-4267 for questions relating to this notice. |
|---|
| Quantity in Commerce | 13 |
|---|
| Distribution | Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = MUJ
|
|---|
