| Date Initiated by Firm | October 01, 2018 |
|---|
| Create Date | January 09, 2019 |
|---|
| Recall Status1 |
Terminated 3 on April 10, 2020 |
| Recall Number | Z-0705-2019 |
|---|
| Recall Event ID |
81751 |
| 510(K)Number | K172848 |
|---|
| Product Classification |
System, radiation therapy, charged-particle, medical - Product Code LHN
|
| Product | MEVION S250i |
|---|
| Code Information |
DI: (01)00864366000124 Serial Number: S250i-0007 |
| FEI Number |
3007087027
|
Recalling Firm/
Manufacturer |
Mevion Medical Systems, Inc.
300 Foster St
Littleton MA 01460-2017
|
| For Additional Information Contact |
978-540-1500 |
|---|
Manufacturer Reason
for Recall | Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped |
|---|
FDA Determined
Cause 2 | Software Manufacturing/Software Deployment |
|---|
| Action | On-site Mevion Field Service Engineer communicated with the firm and is in
daily communication with the single affected consignee. |
|---|
| Quantity in Commerce | 1 unit |
|---|
| Distribution | DC |
|---|
| 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
|
|---|
