Mevion S250 and S250i Proton Therapy Systems hand recall
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Why was Mevion S250 and S250i Proton Therapy Systems hand recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All theryapy systems, all hand pendant serial numbers. Therapy system UDI 00864366000100 and UDI 00864366000124.
- Product
- Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
- Recalling firm
- Mevion Medical Systems, Inc.
- Quantity
- 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.
- Recall date
- April 6, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)