Date Initiated by Firm | February 01, 2022 |
Create Date | March 25, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0827-2022 |
Recall Event ID |
89758 |
510(K)Number | K120676 K172848 |
Product Classification |
System, radiation therapy, charged-particle, medical - Product Code LHN
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Product | Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808) |
Code Information |
All theryapy systems, all hand pendant serial numbers. Therapy system UDI 00864366000100 and UDI 00864366000124. |
Recalling Firm/ Manufacturer |
Mevion Medical Systems, Inc. 300 Foster St Littleton MA 01460-2017
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For Additional Information Contact | Mevion Customer Service 978-540-1500 |
Manufacturer Reason for Recall | Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room. |
FDA Determined Cause 2 | Component design/selection |
Action | Mevion has voluntarily recalled Hand Pendants for S250 and S250i Proton Therapy Systems. All distributed Hand Pendants have been inspected for the identified defect and those that failed inspection have been removed from service following technical service bulletin TSB0048. Subsequent Urgent Medical Device Recall Notice dated 02/11/2022 was hand delivered by on-site field service engineers. Customers are instructed to complete and return the acknowledgement receipt. Please contact Mevion Customer service (robyn.walker@mevion.com) with any questions or concerns. |
Quantity in Commerce | 39 (36 US, 3 OUS) |
Distribution | Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands. |
Total Product Life Cycle | TPLC Device Report |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = LHN
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