| Date Initiated by Firm | March 05, 2014 |
|---|
| Date Posted | March 22, 2014 |
|---|
| Recall Status1 |
Terminated 3 on April 03, 2014 |
| Recall Number | Z-1271-2014 |
|---|
| Recall Event ID |
67657 |
| 510(K)Number | K120676 |
|---|
| Product Classification |
System, radiation therapy, charged-particle, medical - Product Code LHN
|
| Product | MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy
Product Usage: Proton Radiation Therapy |
|---|
| Code Information |
S250-0001 |
| FEI Number |
3007087027
|
Recalling Firm/
Manufacturer |
Mevion Medical Systems, Inc.
300 Foster St
Littleton
MA
01460-2017
|
| For Additional Information Contact | Robyn Kressin
978-540-1500 |
|---|
Manufacturer Reason
for Recall | Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields |
|---|
FDA Determined
Cause 2 | Software design |
|---|
| Action | Mervion issued an Important Safety Notice letter on March 5, 2014 by visit to sites to the single customer using the product to prevent the use of multiple isocenters treatment modalities. The letter identified the affected product, problem and actions to be taken. For questions call 978-540-1555. |
|---|
| Quantity in Commerce | 1 unit |
|---|
| Distribution | USA Nationwide Distribution in the state of MO |
|---|
| 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 = LHN
|
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