| Date Initiated by Firm | October 19, 2020 |
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| Create Date | November 24, 2020 |
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| Recall Status1 |
Terminated 3 on August 31, 2021 |
| Recall Number | Z-0485-2021 |
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| Recall Event ID |
86693 |
| 510(K)Number | K172848 |
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| Product Classification |
System, radiation therapy, charged-particle, medical - Product Code LHN
|
| Product | MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation |
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| Code Information |
Serial Numbers: MEVION S250-0001 MEVION S250-0002 MEVION S250-0003 MEVION S250-0004 MEVION S250-0005 MEVION S250-0006 MEVION S250-0007 MEVION S250-0008 UDI: 01)00864366000100 (11) 131209 (01)00864366000100 (11)150526 (01)00864366000100 (11)150113 (01)00864366000100 (11)150430 (01)00864366000100 (11)160127 (01)00864366000100 (11)160603 (01)00864366000124 (11) 180220 (01)00864366000124 (11) 181219 |
| FEI Number |
3007087027
|
Recalling Firm/
Manufacturer |
Mevion Medical Systems, Inc.
300 Foster St
Littleton
MA
01460-2017
|
| For Additional Information Contact | SAME
978-540-1500 |
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Manufacturer Reason
for Recall | Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur |
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FDA Determined
Cause 2 | Device Design |
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| Action | Mevion issued User Notice by mail or FedEx, with return receipt confirmation on October 22, 2020. The letter states reason for recall, health risk and action to take:
The User should actively monitor the TC screen during beam delivery. In the
event the TC screen beam information appears blank during Beam On , the user should:
Immediately suspend treatment by selecting Beam Off on the Beam
Control Box.
Record the MU counts displayed on the HMUC before any other action is
taken.
Consult physics to make manual adjustments of the plan.
Notify Field Service to retrieve machine records of the partial beam
delivery.
Resumption of treatment requires Setup workflow to be repeated.
Corrective Action
All users should be notified of this scenario and the proper response.
Please contact Mevion Customer service with any questions or concerns.
Please distribute this notice to all users of the Mevion Medical Systems device at your organization who may be affected by this issue
User confirmation of receipt shall also be received from each affected customer site. Customer Service Engineers are also permanently in working residence at customer sites and will ensure awareness of the issue. |
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| Quantity in Commerce | 8 units |
|---|
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of DC, FL, MO, NJ, OK and the country of Netherlands. |
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| 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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